<h2>Advancing therapy with iGlarLixi*</h2>
<h3>Differentiation from complex insulin regimens, including the premixed insulin IDegAsp</h3>

<h3 style="text-align: center;">Current unmet needs in T2D</h3>

<ul>
 <li>Despite advances in technology and therapeutics, many people with&nbsp;T2D across the globe fail to meet their glycemic goals1–5</li>
 <li>This may be attributed to&nbsp;therapeutic inertia&nbsp;due to several patient-and physician-related barriers to treatment advancement, including perceived treatment complexity, fear of hypoglycemia, weight gain and stepwise treatment approaches6,7</li>
 <li>Long-term insufficient glycemic control leads to a&nbsp;“dysglycemic legacy”&nbsp;and is associated with an increased risk of complications;7&nbsp;achieving blood glucose targets may play an important role in reducing the risk of MACE8,9</li>
 <li>Due to the progressive nature of T2D,&nbsp;treatment advancement to insulin-based therapiesis&nbsp;often needed to maintain glycemic control</li>
 <li>In order to overcome therapeutic inertia and the resulting dysglycemic legacy, there is a&nbsp;clinical need for the timely therapeutic advancement of injectable therapy&nbsp;in people with inadequate glycemic control</li>
 <li>Several insulin advancement options are available following insufficient control with basal insulin, including the progressive addition of a rapid-acting insulin to basal insulin, premixed insulin, addition of a GLP-1 RA, or FRCs</li>
</ul>

<h3 style="text-align: center;">iGlarLixi versus other insulin advancement options</h3>

<ul>
 <li>Both direct (RCTs) and indirect treatment comparisons of insulin advancement options play an important role in identifying potential, clinically-relevant treatment options for people with T2D insufficiently controlled on basal insulin10–12</li>
 <li>In a NMA of RCTs,&nbsp;it was shown that iGlarLixi is associated with an improved HbA1c reduction from baseline versus premixed insulin&nbsp;(with a similar or improved safety profile compared with other intensification options)†10</li>
 <li>In the SoliMix RCT,&nbsp;iGlarLixi was found to provide improved HbA1c control with better weight change and less hypoglycemia than twice-daily BIAsp3011</li>
 <li>In a recent ITCcomparing iGlarLixi and IDegAsp, it was shown that iGlarLixi may offer clinical benefit in glucose control and bodyweight change in people who require both basal and meal-time intervention†12</li>
 <li>Based on the benefits observed in a RCT and ITC, FRCs, such as iGlarLixi, may offer a&nbsp;&nbsp;suitable alternative to other intensification options&nbsp;in adults with T2D, demonstrating benefits in HbA1c control and body weight change11,12</li>
</ul>

The content of this infographic summarizes key points discussed during an educational video-on-demand with Professor Philip Homeand Dr Khadija Hafidh. *iGlarLixi is a fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide. †Note, this study was an indirect comparison of products across different studies and, as such, definitive conclusionscannot be drawn.

Abbreviations

References

Advancing Therapy with iGlarLixi

TYPE-2-DIABETES

DIABETES

<h2>Key takeaway</h2>
Based on the conclusions from a consensus group meeting (involving expert, multidisciplinary panel), this narrative review provides HCPs with practical recommendations on several areas* for treatment simplification
Treatment simplification†&nbsp;in patients with T2D, when suitable, eases disease and treatment burden
<ul>
 <li>Can be achieved‡with clear guidance, a personalized approach and open communication between HCPs, individuals with T2D and caregivers</li>
 <li>Overall, there is a need to raise awareness on treatment simplification and, change the “mindset” of not modifying treatment plan or considering complex insulin treatments as the best, final option</li>
 <li>Tools and solutions to help HCPs address the unmet need of simplifying complex 
 <ul>
 <li>Telemedicine and virtual consultations</li>
 <li>Continuous glucose monitoring</li>
 <li>Use of digital application</li>
 <li>Patient support programs</li>
 </ul></li>
</ul>

<h2>Why this matters</h2>
T2D,&nbsp;often requires treatment intensification over time to maintain&nbsp;glycemic control&nbsp;and to&nbsp;prevent&nbsp;or&nbsp;delay longterm complications
Treatment intensification represents&nbsp;complex treatment regimen&nbsp;which often is challenging and has:
<ul>
 <li>
 Negative impact on QoL</li>
 <li>
 Difficulties in adherence</li>
</ul>
Current clinical guidelines are mostly&nbsp;focused on the elderly patients and treatment intensification
<ul>
 <li>But lack in clear guidance&nbsp;on&nbsp;treatment simplification</li>
</ul>
Consensus statement by an expert, multidisciplinary panel provided HCPs with practical recommendations on simplifying complex insulin treatment strategies in people with T2D.

<h2>Key highlights</h2>
<h3>Multidisciplinary consensus method for developing recommendations</h3>
<ul>
 <li>Expert multidisciplinary group convened to identify and address the unmet need to simplify T2D treatment</li>
 <li>Literature review conducted on complex insulin treatment simplification</li>
 <li>Considered practical recommendations to simplify unnecessarily complex insulin regimen§</li>
 <li>2-day expert consensus group discussion on treatment simplification¶</li>
</ul>
<h3>Recommendations following the discussions of the consensus group</h3>
<h4>Terminology</h4>
<ul>
 <li>
 Number of&nbsp;terms are used interchangeably&nbsp;in the published literature</li>
 <li>
 It is important to define&nbsp;<a href="${link:{uuid:{a9e1416d-8896-47bc-bb7a-a9b0dc735910},repository:{dam},path:{/Portal/KSA/Articles/recommendations-on-treatment-simplification-of-complex-insulin-regimens/PDF/Common-terminologies--1-.pdf}}}" target="_blank">common terminologies</a>&nbsp;to aid HCP understanding&nbsp;and enable clear&nbsp;peer-to-peer communication&nbsp;with the person receiving treatment</li>
</ul>
<h4>Recommendations</h4>
<ul>
 <li>Simplification&nbsp;is considered the most appropriate&nbsp;terminology&nbsp;to describe reducing the number of insulin injections (including discontinuation) and adapting the treatment strategy to take into account each person’s circumstances</li>
 <li>HCPs&nbsp;should&nbsp;make efforts&nbsp;to&nbsp;use this terminology consistently&nbsp;in conversations&nbsp;with individuals with T2D and/or their carers, as well as&nbsp;other HCPs, to&nbsp;avoid confusion</li>
</ul>
<h4>Current evidence and treatment landscape</h4>
<ul>
 <li>FRCs and premixed insulins&nbsp;can provide an avenue for treatment simplification</li>
 <li>ADA guidelines#&nbsp;recommend the use&nbsp;of an FRC of basal insulin and a GLP-1 RA, in addition to OADs</li>
 <li>2nd&nbsp;generation insulin analog&nbsp;is preferred because of an improved safety profile vs 1st generation analog</li>
</ul>
<h4>Recommendations</h4>
<ul>
 <li>Current clinical guidelines&nbsp;should be developed further to provide clear and&nbsp;specific guidance on simplifying treatment</li>
 <li>They should&nbsp;aid in identifying clinical situations&nbsp;where&nbsp;simplification&nbsp;would be&nbsp;appropriate,&nbsp;and if possible, how it can be achieved</li>
</ul>
<h4>Personalization of t2d care and psychological aspects</h4>
<ul>
 <li>
 Complex treatment&nbsp;regimen frequently&nbsp;compromises&nbsp;individual&nbsp;QoL</li>
 <li>
 It is important to consider&nbsp;psychological impact&nbsp;of complex therapy</li>
</ul>
<h4>Recommendations</h4>
<ul>
 <li>HCPs&nbsp;should consider&nbsp;simplification&nbsp;as a means of&nbsp;personalizing therapeutic choices&nbsp;using a shared decision-making approach,&nbsp;decision aids&nbsp;and&nbsp;open communication&nbsp;with&nbsp;individuals&nbsp;and/or&nbsp;caregivers</li>
 <li>Cognitive capabilities&nbsp;and&nbsp;emotional well-being, alongside overall&nbsp;QoL, treatment&nbsp;burden and satisfaction&nbsp;with the current treatment plan should also be evaluated</li>
 <li>PROMs&nbsp;may also provide a&nbsp;useful tool&nbsp;for considering a&nbsp;person’s experience of T2D therapy&nbsp;and estimating treatment burden. Once treatment has commenced, re-assessment and communication should be conducted on an ongoing basis</li>
 <li>These&nbsp;evaluations and discussions&nbsp;should be&nbsp;individualized and occur&nbsp;no less than twice a year. The individual with T2D and their caregivers&nbsp;should be involved in all&nbsp;decision-making&nbsp;and setting of&nbsp;therapeutic goals</li>
</ul>
<h4>Candidates for treatment simplification</h4>
<ul>
 <li>Treatment simplification should be considered for the people with T2D to improve health outcomes or QoL</li>
 <li>There is&nbsp;<a href="${link:{uuid:{db2292ee-41cd-4110-b05b-de2ea7e974a0},repository:{dam},path:{/Portal/KSA/Articles/recommendations-on-treatment-simplification-of-complex-insulin-regimens/PDF/List-of-triggers.pdf}}}" target="_blank">list of triggers</a>&nbsp;for considering treatment simplification</li>
</ul>
<h4>Recommendations</h4>
<ul>
 <li>Where possible,&nbsp;treatment simplification&nbsp;should be considered for all individuals with T2D receiving&nbsp;a complex insulin therapy&nbsp;regimen</li>
 <li>Triggers for considering simplification&nbsp;should include people who are experiencing&nbsp;poor glycemic control, difficulties with&nbsp;adherence&nbsp;and&nbsp;self-management, severe or frequent hypoglycemic&nbsp;episodes&nbsp;or substantial&nbsp;weight gain</li>
 <li>Individuals with&nbsp;comorbidities, those with&nbsp;cognitive impairments, the&nbsp;frail, those with&nbsp;limited life expectancies, those with a&nbsp;history of falls and instances&nbsp;where current treatment plans&nbsp;negatively impact on QoL&nbsp;should also be considered&nbsp;for simplification</li>
</ul>
<h4>Simplification of complex insulin regimens</h4>
<ul>
 <li>Key consideration when simplifying regimen is safely balancing: 
 <ul>
 <li>Risk of developing long-term complications</li>
 <li>Symptom burden or severe hyperglycemia</li>
 <li>QoL and convenience**</li>
 </ul></li>
</ul>
<h4>Recommendations</h4>
<ul>
 <li>In line with&nbsp;ADA recommendations, treatment modifications&nbsp;should be conducted in a&nbsp;stepwise manner. GLP-1 RAs should be&nbsp;considered an integral part of simplified treatment models</li>
 <li>If&nbsp;OADs, a GLP-1 RA&nbsp;or&nbsp;basal insulin&nbsp;alone have been insufficient in providing adequate glycemic control,&nbsp;a GLP- 1 RA&nbsp;and basal insulin&nbsp;combination&nbsp;should be administered in an&nbsp;FRC or as a free combination</li>
</ul>
<h4>Clinical situations–simplification may be difficult to impliment</h4>
<ul>
 <li>Simplifying treatment&nbsp;may be difficult in some circumstances such as: 
 <ul>
 <li>OADs and non-insulin-based injectable therapies can be contraindicated in certain people or individual may be intolerant to such therapies</li>
 </ul></li>
</ul>
<h4>Recommendations</h4>
<ul>
 <li>All individuals should be&nbsp;assessed periodically&nbsp;for&nbsp;suitability&nbsp;for&nbsp;treatment simplification. However, in some instances complex insulin regimens may still be the most appropriate form of treatment 
 <ul>
 <li>For such individuals,&nbsp;complex treatment plans need to be followed in line&nbsp;with current clinical guidance and supported by appropriate follow-up</li>
 </ul></li>
</ul>

<ul>
 <li>These&nbsp;individuals&nbsp;should still&nbsp;be regularly reconsidered for simplification&nbsp;and guidelines should be referred to frequently to determine if simplification has become possible for an individual</li>
 <li>Additionally,&nbsp;educational support programs&nbsp;and telehealth services&nbsp;can be utilized to ease the burden of complicated therapy strategies by providing information about self-management</li>
</ul>
* Confusing terminologies, current evidence and treatment landscape, personalized care and psychological aspects, candidates for treatment simplification, simplification of complex insulin regimens, clinical situation where simplification may be difficult to implement †&nbsp;Without compromising therapeutic efficacy and safety ‡&nbsp;Although, not always implemented in clinical practice §&nbsp;With the aim of achieving individualized glycemic goals, reducing frequency of hypoglycemia, weight gain prevention and an improvement in QoL ¶&nbsp;Evaluated terminology used, current evidence and treatment landscape and personalization of T2D care and psychological aspects #&nbsp;When individual require an injectable therapy ** With respect to incorporating the treatment plan into their daily routine
For additional details, refer the source publication (<a href="https://link.springer.com/article/10.1007/s13300-022-01222-2" target="_blank">Jude EB, et al.</a>)

Abbreviation

Reference

Recommendations on treatment simplification of complex insulin regimens to improve clinical outcomes in patients with T2DM

A meta-analysis of observational studies and randomized controlled trials on the relationship between low-density lipoprotein cholesterol and lipid-lowering agents and the risk of stroke.
The findings from this systematic review and meta-analysis can be useful to identify the optimal low-density lipoprotein cholesterol (LDL-C) range to prevent the risk of stroke and plan future studies with different LDL-C targets and lipid-lowering agents (LLAs).

<h2>Key Takeaway</h2>
This systematic review and meta-analysis evaluating the impact of LDL-C levels from cohort studies and LLAs from randomized controlled trials (RCTs) on the risk of different types of strokes demonstrated:
<ul>
 <li>Non-significant trend towards a higher risk of hemorrhagic stroke for all investigated LDL-C levels.</li>
 <li>Significantly higher risk of ischemic stroke with higher LDL-C levels (&gt;70 mg/dL).</li>
 <li>Large effect on all strokes and ischemic strokes, but no significant effect on hemorrhagic strokes by statin and non-statin LLAs.</li>
</ul>
Overall, the data did not show any significant association between LDL-C thresholds and different LLAs and the risk of hemorrhagic stroke.
<ul>
 <li>However, most effects seen in the present analysis were subject to high levels of heterogeneity.</li>
 <li>Thus, well-designed studies are still warranted to determine the effects of low to extremely low LDL-C levels on hemorrhagic stroke and the role of LLAs.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>The effects of dyslipidemia on the pathogenesis of stroke are less clear and the relationship between cholesterol and ischemic stroke is inconsistent.</li>
 <li>The impact of LLAs on stroke types has also not been well established.</li>
 <li>Due to the paucity of studies and conflicting findings, this meta-analysis was conducted to better understand the relationship between low LDL-C levels and various types of strokes based on findings from observational studies and the impact of LLAs and risk of different types of strokes based on RCTs.</li>
</ul>

<h2>Study Design</h2>
<ul>
 <li>Prospective cohort studies and RCTs† published up to 1 September 2019 were searched using PubMed, Embase, and Scopus databases.</li>
 <li>The primary exposure of interest for cohort studies was LDL-C level and primary outcomes were different types of strokes.</li>
 <li>The primary outcome of RCTs was stroke</li>
 <li>Meta-analyses were performed by levels of achieved LDL-C (≤1.3 mmol/L, 1.3 to &lt;1.8 mmol/L, and ≥1.8 mmol/L), statin or non-statin groups, primary vs secondary prevention, and specific type of stroke—ischemic and hemorrhagic.</li>
</ul>

<h2>Key Results</h2>
Cohort studies:
Characteristics of included cohort studies:
<ul>
 <li>Eleven cohort studies involving 355,591 patients with 11,888 events were included in the meta-analysis</li>
 <li>All studies included both sexes and the mean follow-up duration was 9.9 years (range: 4.9–19 years)</li>
</ul>
Association between LDL-C levels and stroke observed in cohort studies:
<ul>
 <li>The highest LDL-C quartile was not associated with stroke events vs the lowest LDL-C quartile (hazard ratio [HR] = 1.032; P = 0.412; n = 3 studies; I2&nbsp;= 0%).</li>
 <li>Patients in the highest LDL-C quartile had a lower risk of hemorrhagic strokes (HR = 0.913; P = 0.012; n = 7 studies; I2 = 0%) and a higher risk of ischemic stroke (HR = 1.105; P &lt;0.001; n = 7 studies; I2&nbsp;= 0%).</li>
 <li>No significant association was seen between LDL-C and intracerebral hemorrhage events (HR = 0.99; P = 1.0; n = 2 studies; I2&nbsp;= 0%).</li>
 <li>Sensitivity analysis: Pooled effect estimates were similar for the association between LDL-C and hemorrhagic stroke (HR = 0.91) and LDL-C and ischemic stroke (HR = 1.10).</li>
</ul>
RCTs:
Characteristics of included RCTs:
<ul>
 <li>Eighteen RCTs published between 2002 and 2018 involving 165,988 patients were included in the meta-analysis</li>
 <li>Across studies, the number of patients ranged from 2,107 to 27,564 and the proportion of men ranged from 48.3–82.2%, with a mean age of 63.1 years</li>
 <li>The mean follow-up duration from baseline to endpoint was 4.1 years</li>
 <li>The baseline and achieved LDL-C levels were 2.25–4.1 mmol/L and 0.78–3.1 mmol/L, respectively</li>
</ul>

<table align="center" border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="4" rowspan="1" style="background-color: rgb(244, 242, 246); text-align: center; width: 50%;">LDL-C levels achieved</td>
 <td colspan="2" rowspan="1" style="background-color: rgb(244, 242, 246); width: 25%;">Statin vs non-statin/ 
 combination therapy</td>
 <td colspan="2" rowspan="1" style="background-color: rgb(244, 242, 246); width: 25%;">Primary vs secondary prevention</td>
 </tr>
 <tr>
 <td style="width: 50%;">Effect of LLAs</td>
 <td style="width: 50%;">&nbsp;≤ 1.3 mmol/L</td>
 <td style="width: 50%;">1.3 &nbsp;≤ 1.8 mmol/L</td>
 <td style="width: 50%;">≥1.8 mmol/L</td>
 <td style="width: 25%;">Statin</td>
 <td style="width: 25%;">Non-statin</td>
 <td style="width: 25%;">Primary</td>
 <td style="width: 25%;">Secondary</td>
 </tr>
 <tr>
 <td style="width: 50%;">All strokes&nbsp;</td>
 <td style="width: 50%;">RR = 0.81 
 p &lt; 0.001 
 I2&nbsp;= 27% 
 n = 3</td>
 <td style="width: 50%;">RR = 0.83 
 p = 0.299 
 I2&nbsp;= 72% 
 n = 3</td>
 <td style="width: 50%;">RR = 0.88 
 p = 0.008 
 I2&nbsp;= 53% 
 n = 13</td>
 <td style="width: 25%;">RR = 0.82 
 p = 0.011 
 I2&nbsp;= 56% 
 n = 15</td>
 <td style="width: 25%;">RR = 0.81 
 p &lt; 0.001 
 I2&nbsp;= 0.0% 
 n = 4</td>
 <td style="width: 25%;">RR = 0.854 
 p &lt; 0.001 
 I2&nbsp;= 52.7% 
 n = 17</td>
 <td style="width: 25%;">RR = 0.90 
 p = 0.092 
 I2&nbsp;= 24.5% 
 n = 2</td>
 </tr>
 <tr>
 <td style="width: 50%;">Ischemic Strokes</td>
 <td style="width: 50%;">RR = 0.78 
 I2&nbsp;= 0.0% 
 n = 3</td>
 <td style="width: 50%;">RR = 0.76 
 p = 0.104 
 I2&nbsp;= 56.7% 
 n = 3</td>
 <td style="width: 50%;">RR = 0.75 
 p &lt; 0.001 
 I2&nbsp;= 0.0% 
 n = 4</td>
 <td style="width: 25%;">
 RR = 0.76 I2&nbsp;= 32% 
 p &lt; 0.001 
 n = 6</td>
 <td style="width: 25%;">RR = 0.77 
 p &lt; 0.001 
 I2&nbsp;= 0.0% 
 n = 4</td>
 <td style="width: 25%;">-</td>
 <td style="width: 25%;">-</td>
 </tr>
 <tr>
 <td style="width: 50%;">Hemorrhagic strokes‡</td>
 <td style="width: 50%;">RR = 1.14 
 I2&nbsp;= 43.6%&nbsp; 
 n = 3</td>
 <td style="width: 50%;">RR = 1.20 
 p = 0.301 
 I2&nbsp;= 0.0% 
 n = 2</td>
 <td style="width: 50%;">RR = 1.25 
 p = 0.289 
 I2&nbsp;= 57.9% 
 n = 5</td>
 <td style="width: 25%;">RR = 1.23&nbsp; 
 p = 0.219 
 I2&nbsp;= 47.4% 
 n = 6</td>
 <td style="width: 25%;">RR = 1.16 
 p = 0.232 
 I2&nbsp;= 16.5% 
 n = 4</td>
 <td style="width: 25%;">-</td>
 <td style="width: 25%;">-</td>
 </tr>
 </tbody>
</table>

<h2>Limitations</h2>
<ul>
 <li>Relatively high heterogeneity was observed in the link between LDL levels and stroke and between studies.</li>
 <li>There was no sufficient statistical power and low level of type I and II error for RCTs on hemorrhagic stroke.</li>
</ul>
*For additional details and inclusion and exclusion criteria for cohort studies/RCTs, please refer to the source publication Banach M, et al. †RCTs were also searched on Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Web of Science by Clarivate and www.clinicaltrials.gov register. ‡Statin therapy was compared with combination therapy

Relationship Between LDL-C LLTs and Risk of Stroke

DYSLIPIDEMIA

CARDIOLOGY

<h2>Real-World Outcomes of Addition of Insulin Glargine 300 U/mL (Gla-300) to GLP-1RA Therapy in People With Type 2 Diabetes (PWD2): The DELIVER-G Study</h2>
<h3>Introduction:</h3>
<ul>
 <li>Despite clear evidence for the efficacy of glucagon-like peptide-1 receptor agonist (GLP-1RA), some patients do not experience lasting glycemic control and require treatment intensification1,2</li>
 <li>For people with type 2 diabetes (PWD2) who experience inadequate glycemic control despite intensification with dual or triple therapy, the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) recommend that sulfonylureas or insulin therapy should also be added, as required3,4</li>
 <li>Clinical studies have demonstrated improved glycemic control and low risk of hypoglycemia and weight gain with the combination of insulin and GLP-1RA; however, data on outcomes when these therapies are used in real-world clinical practice are currently lacking 
 <ul>
 <li>This retrospective study of electronic medical records (EMRs) aimed to determine the impact of adding basal insulin analog Gla-300 to GLP-1RA therapy in PWD2 receiving treatment intensification</li>
 </ul></li>
</ul>

<h3>Methods</h3>
<ul>
 <li>Retrospective analysis of US EMR data source (IBM® Explorys) between March 1, 2014 and March 31, 2020; IBM Explorys includes longitudinal data from &gt;4 million PWD2, representing outpatient, inpatient, and post-acute care settings</li>
 <li>We identified insulin-naïve adult (aged ≥18 years) PWD2 who were receiving GLP-1RAs and subsequently received Gla-300 (index event) between March 1, 2015 and September 30, 2019</li>
 <li>PWD2 were required to have data available for ≥12 months before index (“baseline”) and ≥6 months after index (“follow-up”) 
 <ul>
 <li>Valid glycated hemoglobin (HbA1c)&nbsp;&nbsp;value of 3–15% recorded within 6 months pre-index and in the 3- to 9-month post-index period</li>
 </ul></li>
</ul>
<ul>
 <li>Study assessments included: 
 <ul>
 <li>Change in HbA1c between baseline and follow-up, using the last value recorded within the 3- to 9-month post-index period</li>
 <li>Proportion of patients who achieved target HbA1c (&lt;7% or &lt;8%) in the 6-month follow-up period</li>
 <li>Proportion of patients experiencing hypoglycemia (identified by ICD-9/-10 code, or a blood glucose recording ≤70 mg/dL), or the number of hypoglycemic events in 6-month baseline vs 6-month follow-up periods</li>
 </ul></li>
</ul>

<ul>
 <li>Incidence and event rates (per person per year [PPPY]) of healthcare resource utilization (HCRU) encounters were assessed; HCRU encounters were categorized as inpatient-, emergency department (ED)-, or outpatient-related</li>
 <li>Sensitivity analyses assessed HbA1c reduction and hypoglycemia for patients receiving weekly (exenatide, dulaglutide, or albiglutide) vs daily (exenatide and liraglutide) GLP-1RA therapies</li>
 <li>Study variables were analyzed descriptively, with McNemar’s test used to evaluate differences in categorical variables and paired Student’s t-tests for continuous variables (p&lt;0.05 was considered significant)</li>
</ul>

<h3>Results</h3>
Study sample and baseline characteristics
<ul>
 <li>A total of 271 patients (mean [SD] age: 57.9 [10.8] years) met eligibility criteria (Table&nbsp;1) 
 <ul>
 <li>The most common comorbidities recorded in the 12-month pre-index period were hypertension, hyperlipidemia, and obesity</li>
 <li>156 patients received daily GLP-1RA and 115 received weekly GLP-1RA before treatment intensification with Gla-300</li>
 </ul></li>
</ul>

<ul>
 <li>In the 6-month pre-index period, 8.5% of patients had a hypoglycemic event (event rate: 0.17 PPPY)</li>
</ul>
Table 1. Baseline characteristics
<table border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(244, 242, 246); width: 70%;">&nbsp;</td>
 <td style="background-color: rgb(244, 242, 246); width: 30%;">Mean ± SD or n (%)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Age, years</td>
 <td style="width: 30%;">
 57.9 ± 10.8</td>
 </tr>
 <tr>
 <td style="width: 70%;">Male</td>
 <td style="width: 30%;">
 138 (50.9)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Body mass index, kg/m2</td>
 <td style="width: 30%;">
 35.5 ± 6.3</td>
 </tr>
 <tr>
 <td style="width: 70%;">Baseline HbA1c, %</td>
 <td style="width: 30%;">
 9.16 ±1.51</td>
 </tr>
 <tr>
 <td style="width: 70%;">Patients with hypoglycemia events</td>
 <td style="width: 30%;">
 23 (8.5)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Hypoglycemia event rate, per person per year (SD)</td>
 <td style="width: 30%;">
 0.17 (0.65)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Medications received during baseline period</td>
 <td style="width: 30%;">&nbsp;</td>
 </tr>
 <tr>
 <td style="width: 70%;">Daily GLP-1RA</td>
 <td style="width: 30%;">
 156 (57.6)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Weekly GLP-1RA</td>
 <td style="width: 30%;">
 115 (42.4)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Any oral antidiabetic drug</td>
 <td style="width: 30%;">
 250 (92.3)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Sodium-glucose co-transporter-2</td>
 <td style="width: 30%;">
 113 (41.7)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Dipeptidyl peptidase-4</td>
 <td style="width: 30%;">
 68 (25.1)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Overall number of oral antidiabetic drugs</td>
 <td style="width: 30%;">
 1.97 ± 1.0</td>
 </tr>
 <tr>
 <td style="width: 70%;">Comorbities/complications (ICD-9/-10) in &gt;10% of patients</td>
 <td style="width: 30%;">&nbsp;</td>
 </tr>
 <tr>
 <td style="width: 70%;">Hypertension</td>
 <td style="width: 30%;">
 226 (83.4)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Hyperlipidemia</td>
 <td style="width: 30%;">
 230 (84.9)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Neuropathy</td>
 <td style="width: 30%;">
 44 (16.2)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Obesity</td>
 <td style="width: 30%;">
 111 (41.0)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Depression</td>
 <td style="width: 30%;">
 56 (20.7)</td>
 </tr>
 <tr>
 <td style="width: 70%;">Elixhauser Comorbidity Index</td>
 <td style="width: 30%;">
 3.24 ± 2.03</td>
 </tr>
 </tbody>
</table>
GLP-1RA, glucagon-like peptide-1 receptor agonist ;&nbsp;HbA1c, glycated hemoglobin.

<h3>HbA1c</h3>
<ul>
 <li>Overall, HbA1c was significantly reduced after treatment intensification with addition of Gla-300 (−0.97 ± 1.6%; p&lt;0.0001) (Figure 1A)</li>
 <li>Significantly more patients achieved HbA1c control&nbsp; (&lt;7% or &lt;8%) during follow-up after addition of Gla-300 (Figure 1B)</li>
</ul>
Figure 1. Baseline and follow-up values for (A) HbA1c, and&nbsp; (B) Proportion of patients achieving target HbA1c goals

<h3>Results: Glycemic control and Body Weight</h3>
HbA1c by GLP-1RA regimen frequency
<ul>
 <li>Addition of Gla-300 to either daily (n=156) or weekly (n=115) GLP-1RA resulted in a similar, significant decrease in HbA1c (daily: −0.89 ± 1.62; p&lt;0.001; weekly: −1.07 ± 1.58; p&lt;0.001) (Figure 2).</li>
</ul>
Weight and body mass index (BMI)
<ul>
 <li>No significant changes in weight (108.0 vs 108.4 kg) or BMI (35.8 vs 36.1 kg/m2) were seen with addition of Gla-300 to GLP-1RAs (baseline vs follow-up, respectively) 
 <ul>
 <li>However, a 3.9% increase in patients with BMI ≥35 kg/m2 was seen (51.5% vs 55.4%; p=0.046)</li>
 </ul></li>
</ul>
Figure 2. Change in HbA1c from baseline to follow-up, stratified by GLP-1RA regimen frequency

<h3>Results: Hypoglycemia</h3>
<ul>
 <li>No changes in overall incidence or event rate of hypoglycemia were seen following addition of Gla-300 (Figure 3)</li>
 <li>When analyzed by GLP-1RA regimen, increases in the incidence of hypoglycemia (from 3.9% at baseline to 8.3% at follow-up; p=0.020) and hypoglycemia event rate (from 0.21 PPPY to 0.44 PPPY; p=0.017) were observed at follow-up in patients using daily GLP-1RA</li>
 <li>No significant differences were seen at follow-up in patients using weekly GLP-1RA</li>
</ul>
Figure 3. (A) Incidence of hypoglycemia, and (B) hypoglycemia event rate (PPPY), at 6 months pre- and 6 months post-index period

GLP-1RA, glucagon-like peptide-1 receptor agonist ;&nbsp;HbA1c, glycated hemoglobin;&nbsp;ED, emergency department;&nbsp;PPPY, per person per year

<h3>Result: Healthcare resource utilization</h3>
<ul>
 <li>Significant reduction in the incidence of all-cause (98.9% vs 95.2%; p=0.008) and diabetes-associated outpatient visits (93.7% vs 82.3%; p&lt;0.0001) were recorded between baseline and 6-month follow-up periods (Table 2)</li>
 <li>A reduction in all-cause (10.2 vs 9.0 PPPY; p=0.005) and diabetes-associated outpatient visits (5.7 vs 4.2 PPPY; p&lt;0.0001) were also recorded between baseline and 6-months follow-up periods</li>
 <li>No other significant changes in the incidence or rates of HCRU were recorded, including in hypoglycemia-associated HCRU</li>
</ul>
Table 2. HCRU at baseline and follow-up

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">&nbsp;</td>
 <td colspan="2" rowspan="1" style="background-color: rgb(244, 242, 246);">All-cause</td>
 <td colspan="2" rowspan="1" style="background-color: rgb(244, 242, 246);">Diabetes-associated</td>
 <td colspan="2" rowspan="1" style="background-color: rgb(244, 242, 246);">Hypoglycemia-associated</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">&nbsp;</td>
 <td style="background-color: rgb(244, 242, 246);">BL</td>
 <td style="background-color: rgb(244, 242, 246);">FU</td>
 <td style="background-color: rgb(244, 242, 246);">BL</td>
 <td style="background-color: rgb(244, 242, 246);">FU</td>
 <td style="background-color: rgb(244, 242, 246);">BL</td>
 <td style="background-color: rgb(244, 242, 246);">FU</td>
 </tr>
 <tr>
 <td colspan="7">Incidence, n(%)</td>
 </tr>
 <tr>
 <td>Incidence visits</td>
 <td>21 (7.75)</td>
 <td>25 (9.23)</td>
 <td>13 (4.80)</td>
 <td>15 (5.54)</td>
 <td>1 (0.37)</td>
 <td>0 (0.00)</td>
 </tr>
 <tr>
 <td>ED visits</td>
 <td>31 (11.44)</td>
 <td>27 (9.96)</td>
 <td>14 (5.17)</td>
 <td>11 (4.06)</td>
 <td>0 (0.00)</td>
 <td>1 (0.37)</td>
 </tr>
 <tr>
 <td>Outpatient visits</td>
 <td>268 (98.89)</td>
 <td>258 (95.20)</td>
 <td>254 (93.73)</td>
 <td>223 (82.29)</td>
 <td>17 (6.27)</td>
 <td>19 (7.01)</td>
 </tr>
 <tr>
 <td colspan="7">Event rate, events (PPPY)</td>
 </tr>
 <tr>
 <td>Inpatient visits</td>
 <td>35 (0.26)</td>
 <td>27 (0.20)</td>
 <td>17 (0.13)</td>
 <td>16 (0.12)</td>
 <td>1 (0.0074)</td>
 <td>0 (0.00)</td>
 </tr>
 <tr>
 <td>ED visits</td>
 <td>38 (0.28)</td>
 <td>32 (0.24)</td>
 <td>17 (0.13)</td>
 <td>11 (0.08)</td>
 <td>0 (0.00)</td>
 <td>1 (0.0074)</td>
 </tr>
 <tr>
 <td>Outpatient visits</td>
 <td>1382 (10.20)</td>
 <td>1224 (9.03)</td>
 <td>778 (5.74)</td>
 <td>563 (4.15)</td>
 <td>28 (0.21)</td>
 <td>35 (0.26)</td>
 </tr>
 <tr>
 <td>Inpatient days (PPPY)</td>
 <td>72 (0.53)</td>
 <td>82 (0.61)</td>
 <td>41 (0.30)</td>
 <td>45 (0.33)</td>
 <td>8 (0.06)</td>
 <td>0 (0.00)</td>
 </tr>
 </tbody>
</table>

Bolded values indicates significance (p&lt;0.01) vs baseline. BL, baseline;&nbsp;ED, emergency department;&nbsp;FU, follow-up;&nbsp;PPPY, per person per year

<h3>Conclusion</h3>
<ul>
 <li>In US real-world clinical practice, addition of Gla-300 to GLP-1RA therapy significantly improved glycemic control in PWD2 without significantly increasing hypoglycemia 
 <ul>
 <li>Improvements in glycemic control were seen irrespective of the use of daily or weekly GLP-1RAs or baseline HbA1c level</li>
 <li>Observations support ADA/EASD guidelines, noting that insulin should be added to GLP-1RA for PWD2 with inadequate glycemic control requiring treatment intensification1,2</li>
 </ul></li>
</ul>
<ul>
 <li>Addition of Gla-300 led to a ~1% additional reduction in HbA1c and between 2- to 3-times more patients reaching their target HbA1c levels 
 <ul>
 <li>These observations are in line with clinical studies, suggesting Gla-300 added to GLP-1RA provides additional HbA1c lowering vs continuing on GLP-1RA alone3,4</li>
 <li>Observations support ADA/EASD guidelines, noting that insulin should be added to GLP-1RA for PWD2 with inadequate glycemic control requiring treatment intensification1,2</li>
 </ul></li>
</ul>
<ul>
 <li>Intensification with Gla-300 in patients uncontrolled on GLP-1RA did not generally increase the risk of hypoglycemia 
 <ul>
 <li>A small increase may be seen in the subset of patients receiving GLP-1RA therapy daily vs weekly; however, hypoglycemic events were rare, with event rates indicating approximately 1 event every 2 years (0.44 PPPY)</li>
 </ul></li>
</ul>
<ul>
 <li>Addition of Gla-300 led to a reduction in incidence and rate of outpatient HCRU, both overall and diabetes-related</li>
 <li>In summary, intensification of GLP-1RA therapy with Gla-300 was an effective option for improving glycemic control without increasing the risk of hypoglycemia, and resulted in reduction in outpatient resource use over the longer term</li>
</ul>

Real world Evidences

INTEGRATED-DIABETES-CARE

<h2>Key takeaway</h2>
<h3>Achievement and maintenance of optimal glycemic control is important for prevention and/or delay of acute and long-term complications of diabetes through patient-centered care.</h3>
<ul>
 <li>
 Glycemic goals&nbsp;are achieved only when&nbsp;timely and appropriate therapyintensification&nbsp;is carried out when needed.</li>
 <li>
 Numerous studies have shown that use of&nbsp;CGM significantly improves glycemic outcomes&nbsp;in both T1D and T2D.</li>
</ul>
<h3>Daily use of CGM and retrospective CGM data, combined with clinic-based or virtual (telehealth) visits has the potential to reduce therapeutic inertia.</h3>
<ul>
 <li>
 For clinicians:&nbsp;CGM provides&nbsp;accurate glucose information,&nbsp;presented in a format that facilitates rapid interpretation and more informed therapy decision-making; and helps in increasing their&nbsp;efficiency&nbsp;and improve the&nbsp;quality-of-care delivery</li>
 <li>
 For patients:&nbsp;CGM helps to obtain&nbsp;immediate feedback&nbsp;on their medications, dietary habits and other health behaviors affecting their glycemic status; enhances their&nbsp;disease-understanding;&nbsp;and improves&nbsp;treatment satisfaction&nbsp;and&nbsp;adherence&nbsp;to the prescribed regimens</li>
</ul>

<h2>Why this matters</h2>
<h3>Therapeutic inertia (failure to initiate/intensify therapy) is a key contributor of suboptimal glycemic management when therapeutic goals are not reached.</h3>
Clinical guidelines&nbsp;recommend&nbsp;treatment intensification&nbsp;in individuals not meeting their glycemic targets within 3–6 months of initiating treatment.
<ul>
 <li>Median time to&nbsp;treatment intensification&nbsp;may be as long as&nbsp;2.9 years.</li>
 <li>One-year delay&nbsp;in intensification is associated with increased risk of: 
 <ul>
 <li>Myocardial infarction&nbsp;(67%)</li>
 <li>Heart failure&nbsp;(64%)</li>
 <li>Stroke&nbsp;(51%)</li>
 </ul></li>
</ul>
Barriers&nbsp;impacting clinicians’ ability to monitor and adjust therapy:
<ul>
 <li>
 Lack of meaningful, actionable glucose data</li>
 <li>
 Unfamiliarity with interpreting and utilizing glucose data</li>
 <li>
 Time constraints</li>
</ul>
This article reviews the benefits of CGM vs BGM, evidence supporting CGM in management of T1D and T2D, and its use in primary care to facilitate appropriate and more timely therapy adjustments

<h2>Key highlights</h2>
For further details, click on the below hyperlinks.
<ul>
 <li><a href="#" target="_self">Current CGM Technologies</a>
 <ul>
 <li>Commercially available CGM systems for personal use include&nbsp;real-time CGM&nbsp;(rtCGM) and&nbsp;intermittently scanned CGM&nbsp;(isCGM).</li>
 </ul></li>
 <li><a href="#" target="_self">Selecting a CGM device</a>
 <ul>
 <li>The&nbsp;AACE&nbsp;clinical practice guidelines strongly&nbsp;recommend CGM&nbsp;for all persons with diabetes, treated with intensive insulin therapy; however,&nbsp;selecting a CGM device can be individualized&nbsp;to each patient’s preferences and needs.</li>
 </ul></li>
 <li><a href="#" target="_self">Limitations with the use of BGM</a>
 <ul>
 <li>While&nbsp;BGM&nbsp;is the most commonly used method for monitoring glucose levels, it still has important&nbsp;limitations&nbsp;that should be considered.</li>
 </ul></li>
 <li><a href="#" target="_self">Benefits of using CGM vs BGM</a>
 <ul>
 <li>Numerous randomized clinical trials and real-world prospective and observational studies have shown the&nbsp;effectiveness of CGM vs BGM.</li>
 </ul></li>
</ul>

<h2>CGM metrics for clinical assessment of Glycemic control</h2>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="2" rowspan="1" style="background-color: rgb(244, 242, 246);">&nbsp;</td>
 <td>T1D/T2D</td>
 <td>General goals for nonpregnant adults</td>
 <td>Older/ High-Risk (modified goals)</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="2" style="background-color: rgb(244, 242, 246);">Time In Range (TIR)</td>
 <td colspan="1" rowspan="2" style="background-color: rgb(244, 242, 246);">70–180 mg/dL</td>
 <td>Time/ day</td>
 <td>&gt;16 h, 48</td>
 <td>&gt;12 h</td>
 </tr>
 <tr>
 <td>% Time</td>
 <td>&gt;70%</td>
 <td>&gt;50%</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="4" style="background-color: rgb(244, 242, 246);">Time Above Range (TAR)</td>
 <td colspan="1" rowspan="2" style="background-color: rgb(244, 242, 246);">&gt;180 mg/dL</td>
 <td>Time/ day</td>
 <td>&lt;6 h</td>
 <td>-</td>
 </tr>
 <tr>
 <td>% Time</td>
 <td>&lt;25%</td>
 <td>-</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="2" style="background-color: rgb(244, 242, 246);">&gt;250 mg/dL</td>
 <td>Time/ day</td>
 <td>&lt;1 h, 12 m</td>
 <td>&lt;2 h, 24 m</td>
 </tr>
 <tr>
 <td>% Time</td>
 <td>&lt;5%</td>
 <td>&lt;10%</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="4" style="background-color: rgb(244, 242, 246);">Time Below Range (TBR)</td>
 <td colspan="1" rowspan="2" style="background-color: rgb(244, 242, 246);">&lt;70 mg/dL</td>
 <td>Time/ day</td>
 <td>&lt;1 h</td>
 <td>&lt;15 m</td>
 </tr>
 <tr>
 <td>% Time</td>
 <td>&lt;4%</td>
 <td>&lt;1%</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="2" style="background-color: rgb(244, 242, 246);">&lt;54 mg/dL</td>
 <td>Time/ day</td>
 <td>&lt;15 m</td>
 <td>-</td>
 </tr>
 <tr>
 <td>% Time</td>
 <td>&lt;1%</td>
 <td>-</td>
 </tr>
 </tbody>
</table>

The recommended primary goal is to reduce %TBR while increasing %TIR; with improvements in these metrics, %TAR would be reduced and minimized by default.

<h2>Case studies</h2>
Below&nbsp;cases&nbsp;discuss the&nbsp;utility of&nbsp;CGM&nbsp;data for quick interpretation of glycemic patterns, timely initiation and appropriate adjustments in therapy:
For further details, click on the below hyperlinks.
<ul>
 <li><a href="#" target="_self">Case 1 : T2D</a></li>
 <li><a href="#" target="_self">Case&nbsp;2 : T1D</a></li>
</ul>
For additional details, please refer to the source publication Martens TW, et al.

Single injectable treatment may not be enough to get T2DM patient to Glycemic goal

<h2>Prognostic impact of achieving guideline-recommended LDL-C target in secondary prevention: A real-world study</h2>
This real-world study of PMI patients emphasizes the importance of achieving guideline-recommended secondary prevention goals of LDL-C &lt;55 mg/dL and ≤50% from baseline to reduce Mace.

<h2>Main Takeaway</h2>
<ul>
 <li>The incidence of Mace&nbsp;was 12.9% and 23.7% in the group attaining the 2019 goals (LDL-C &lt;55 mg/dL) and in the group attaining 2016 goals (LDL-C &lt;70 mg/dL), respectively.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>The 2019 ESC guidelines recommend a more ambitious target (to achieve LDL-C &lt;55 mg/dL and to reduce it by ≥50% from baseline) than the previous guideline version (LDL-C &lt;70 mg/dL or reduced ≥50% from baseline).</li>
 <li>Data on the reduction of CV events in patients attaining the 2019 ESC goals are lacking in real-world population.</li>
 <li>This study aimed to determine the risk of Mace during follow-up in PMI patients according to the achievement of the guideline-recommended goals in terms of LDL-C reduction.</li>
</ul>

<h2>Study Design</h2>
<ul>
 <li>This was a retrospective analysis of a monocentric observational registry that prospectively enrolled patients hospitalized for ST segment elevation MI and followed-up in PMI ambulatory between January 2011 and February 2019.</li>
 <li>Clinical and demographic data were extracted from digital database, and the clinical events that occurred during follow-up were obtained by telephone interviews or clinical records.</li>
 <li>Endpoints: Mace defined as all-cause death, non-fatal MI, non-fatal stroke, and unplanned revascularization</li>
 <li>LDL-C was collected at baseline and at 1, 6, and 12 months after the events. To define the achievement of target goals, the lower value was collected at follow-up.</li>
 <li>Kaplan-Meier analysis and log-rank test were conducted for comparing patients who achieved LDL-C &lt;55 mg/dL and ≤50% from baseline (group 2019) versus those who achieved LDL-C &lt;70 mg/dL or ≤50% from baseline (group 2016).</li>
 <li>Continuous variables are presented as medians (interquartile ranges).</li>
</ul>

<h2>Key Results</h2>
<ul>
 <li>A total of 1,201 patients were included in the study (median age: 63 [54–72] years; female: 23%; hypertension: 56%; diabetes: 17%; smokers: 38%).</li>
 <li>Baseline LDL-C was 123 (97–148) mg/dL; at follow-up, median LDL-C was 63 (52–78) mg/dL and was significantly reduced from baseline (P &lt;0.0001).</li>
 <li>Between 6 and 12 months, 83% of patients were treated with statins alone (73% with high intensity) and 17% with the addition of ezetimibe.</li>
 <li>In total, 828 patients (69%) achieved the 2016 target, whereas 270 patients (22.5%) also achieved the 2019 target. Median follow-up was 60 (40–77) months.</li>
 <li>Mace incidence was 12.9% and 23.7% in group 2019 and group 2016, respectively (HR = 0.61, 95% CI: 0.42–0.88; P log rank = 0.0087, number needed to treat = 9).</li>
</ul>

Prognostic impact of achieving LDL cholesterol guidelines

<h2>Key takeaway</h2>
Adults with T2D, enrolled in an exercise-based cardiac rehabilitation program showed:
<ul>
 <li>
 Higher incidence of post-exercise hypoglycemia in those on pre-mixed insulin and basal-bolus insulin medications.</li>
 <li>
 Greater reduction in blood glucose was related to greater pre-exercise blood glucose, independent of BMI and total exercise duration.</li>
</ul>

<h2>Why this matters</h2>
Limited studies on SMBG changes post-exercise, especially in adults with T2D on diabetes medications.
<ul>
 <li>This has led to limited understanding of medicationrelated hypoglycemia.</li>
</ul>
Study ascertained if the magnitude of blood glucose reduction and incidence of hypoglycemia were related to the medication regimen

<h2>Study design</h2>
Retrospective review included adults (N = 52) with T2D enrolled in a structured exercise program within a cardiac rehabilitation facility*
<h3>Date collected</h3>
<ul>
 <li>
 Demographics&nbsp;</li>
 <li>
 Medications</li>
 <li>
 Exercise prescription&nbsp;</li>
 <li>
 Patient-reported pre-/post-blood glucose values</li>
</ul>
<h3>Primary outcome</h3>
<ul>
 <li>Magnitude of change in capillary blood glucose levels in pre- to post-exercise&nbsp; 
 <ul>
 <li>Hypoglycemia: Defined as blood glucose ≤4.0 mmol/L</li>
 </ul></li>
</ul>

<h2>Key results</h2>
<h3>52 participants were included (males = 46.2%; mean age = 62.7 years; mean HbA1c level = 7.7%)</h3>
<ul>
 <li>Overall incidence of hypoglycemia in all insulin users = 14.5%</li>
</ul>
<h3>Post-exercise hypoglycemia</h3>
<ul>
 <li>13&nbsp;events reported in&nbsp;10&nbsp;participants†, 42 participants had no event</li>
 <li>Hypoglycemia event group: Mean decrease in blood glucose from pre- to post-exercise =&nbsp;3.5 mmol/L&nbsp;(over a mean exercise duration of 27.9 min)</li>
 <li>Post-exercise hypoglycemia was associated with the prescribed use of pre-mixed insulin: 
 <ul>
 <li>Pre-mixed insulin vs non-insulin users =&nbsp;50%&nbsp;vs&nbsp;3%; P &lt;0.0001</li>
 </ul></li>
</ul>

<ul>
 <li>Post-exercise hypoglycemia was associated with the prescribed use of insulin 
 <ul>
 <li>Basal-bolus vs non-insulin users =&nbsp;11.1%&nbsp;vs&nbsp;3%; P = 0.04</li>
 </ul></li>
</ul>

<h3>Post-exercise-induced reduction in blood sugar</h3>
<ul>
 <li>Greater post-exercise capillary blood glucose reduction (1.6, range 2–11 mmol/L) was related to greater pre-exercise blood glucose (beta):&nbsp;–0.46 mmol/L; P &lt;0.0001 
 <ul>
 <li>Independent of BMI =&nbsp;–0.01 mmol/L&nbsp;per BMI unit; P = 0.78&nbsp;</li>
 <li>Total exercise duration =&nbsp;0.01 mmol/L&nbsp;per minute; P = 0.58&nbsp;</li>
 </ul></li>
</ul>

<ul>
 <li>Hypoglycemic events were less likely to be associated with higher pre-exercise blood glucose (OR:&nbsp;0.42; P &lt;0.03)</li>
</ul>

<h2>Limitations</h2>
<ul>
 <li>
 Retrospective study, focused on hypoglycemia following aerobic exercise</li>
 <li>
 Study could not be controlled for timing of medications and nutritional intake, pre-existing hypoglycemia experience, hypoglycemia fear, or knowledge of hypoglycemia prevention strategies</li>
 <li>
 Individual factors‡ which may affect medication half-life and potentiate effects of hypoglycemic medications were not examined&nbsp;</li>
 <li>
 Analysis was not powered to evaluate the relationship between post-exercise hypoglycemia and different classes of antihyperglycemic agents</li>
</ul>
* Study period: February to December 2012. †&nbsp;Of these, participants were prescribed non-insulin antihyperglycemic medications + insulin combination therapy (n = 5), non-insulin antihyperglycemic medications only (n = 4) or insulin only (n = 1). ‡&nbsp;Such as renal function.

Post-exercise hypoglycemia in relation to medication regimen among adults with type 2 diabetes

<h2>Treatment burden associated with complex insulin regimens in T2D</h2>
<ul>
 <li>Due to the multiple pathophysiological defects and progressive nature of T2D, many individuals will require therapeutic advancement with insulin-based therapies throughout the course of their lives1</li>
 <li>Therapeutic advancement with complex insulin regimens is often associated with an increased burden of disease, contributing to low treatment adherence and reduced quality of life2</li>
</ul>

<h3>Factors impacting adherence to insulin therapy3</h3>

Daily injection 
 frequency

Injection 
 embarrassment

<ul>
 <li>Poor treatment adherence, along with therapeutic inertia, is primarily why people with T2D are experiencing less sustained improvements in a real-world setting compared with RCT data4</li>
 <li>Therapeutic inertia is defined as the failure not only to intensify therapy, but also to de-intensify treatment when people are overtreated5</li>
</ul>

Simple yet effective strategies are required to help overcome these challenges of treatment burden

<ul>
 <li>Treatment simplification offers the opportunity to ease disease burden and may help to reduce polypharmacy and risk of hypoglycemia in adults with T2D2</li>
 <li>Current guidelines support the concept of simplification, but primarily focus on the older adult population and lack clear guidance on how this can be achieved1</li>
</ul>

Treatment simplification with BI + GLP-1 RA FRC

black

The combination of a BI analog and a GLP-1 RA may be a simple and effective way to target the multi-faceted manifestations of T2D and may help reduce the burden and complexity of treatment1

In their main treatment algorithm, the ADA/EASD now recommends BI + GLP-1 RA FRCs as a&nbsp;very high efficacy approach&nbsp;to achieve glycemic goals5

Therapeutic advancement&nbsp;to complex insulin regimens can&nbsp;increase treatment burden&nbsp;for people with T2D, and may be associated with an increased risk of hypoglycemia, reduced treatment adherence and increased body weight
HCPs should regularly assess individual circumstances and needs, and evaluate where it is possible to&nbsp;decrease treatment complexity&nbsp;and the burden of treatment to&nbsp;improve glycemic outcomes&nbsp;on a case-by-case basis
BI + GLP-1 RA FRCs may offer an&nbsp;effective and simple alternative&nbsp;to complex insulin regimens, such as premixed and basal-bolus insulin, to&nbsp;both intensify and simplify treatment

The content of this infographic summarizes key points discussed during an educational video-on-demand with Professor Rory McCrimmon and Dr Alice Cheng. Please note, two FRCs of a basal insulin and a GLP-1 RA are available: iGlarLixi (insulin glargine 100 U/mL + lixisenatide) and IDegLira (insulin degludec + liraglutide).*SoliMix&nbsp;was a multicenter, open-label, randomized study comparing the efficacy and safety of iGlarLixi versus BIAsp 30 in adults with T2D (n=887).&nbsp;DUAL VII&nbsp;was an open-label, two-arm parallel, randomized study comparing the efficacy and safety of IDegLira versus BB in adults with T2D (n=506).&nbsp;SoliComplex&nbsp;was a real-world, retrospective, observational study comparing iGlarLixi and premixed insulin (N=834) or iGlarLixi and BB (N=1070) in adults with T2D advancing on BI. In&nbsp;SoliComplex,&nbsp;data was collected from the US Optum Clinformatics database, therefore the US iGlarLixi pen (Soliqua®&nbsp;100/33) was administered to participants. †For further details and an overview of the supporting data, please refer to the full educational video-on-demand (MAT-GLB-2204912) and the study publications.

Treatment simplification in T2D: A less-is-more approach to help reduce the burden of disease

<h2>Among post-ACS patients from Saudi Arabia:</h2>
<ul>
 <li>A large proportion of patients did not achieve target LDL-C reduction ≥50% and levels &lt;55 mg/dL, as recommended by 2019 ESC/EAS guidelines1</li>
 <li>All patients were prescribed statins and a very small proportion of patients were prescribed add-on LLT. Additionally, a small proportion of patients were on statins pre-ACS</li>
 <li>Gaps in dyslipidemia management and patient education remain despite availability of updated lipid management guidelines</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>The management of dyslipidemiapost-ACS is essential for secondary prevention of CV events</li>
 <li>The global Acute Coronary Syndrome Management (ACOSYM) study reportedthe gap in lipid management post-ACSin non-Western European patients2</li>
 <li>Despite the efficacy of available LLTs,data on patients attaining LDL-C goals are limited and suboptimal in Saudi Arabia</li>
 <li>This study identified the scenario of LDL-C management and the implementation of LLTs for post-ACS Saudi Arabian patientsin real-world clinical practice</li>
</ul>

<h2>Study Design</h2>
The ACOSYM was a prospective, multicenter, observational registry evaluating LDL-C control in patients within 6 months after hospitalization following ACS
Inclusion Criteria
<ul>
 <li>Age ≥18 years</li>
 <li>≤12 weeks of hospitalization for ACS</li>
 <li>Diagnosis of ACS, defined as any group of clinical symptoms compatible with: 
 <ul>
 <li>STEMI&nbsp;</li>
 <li>NSTEMI&nbsp;</li>
 <li>UA</li>
 </ul></li>
</ul>
Study Objectives
<ul>
 <li>Primary objective:&nbsp;Proportion ofpost-ACS patients reaching the four LDL-C goals (&lt;130, &lt;100, &lt;70, and &lt;50 mg/dL) at 6 months</li>
 <li>Secondary objectives:
 <ul>
 <li>LLTs prescribed to patients with ACS</li>
 <li>Proportion of statin-intolerant patients</li>
 <li>Potential barriers to achievingLDL-C targets</li>
 </ul></li>
 <li>Ad hoc analysis:&nbsp;The 2019 ESC/EAS guidelines’ recommendation of achieving LDL-C reduction ≥50% and LDL-C levels &lt;55 mg/dL</li>
</ul>

<h2>Key Results</h2>
<ul>
 <li>Of 201 eligible patients (mean age, 54.4 ±11.1 years),&nbsp;126 (62.7%)&nbsp;patients were assessed for primary outcome as they had ≥1 LDL-C measures available during the follow-up period</li>
 <li>LDL-C levels decreased from&nbsp;115.8 ±46.5mg/dL&nbsp;at baseline to&nbsp;69.0 ± 33.4 mg/dL&nbsp;at target achievement assessment&nbsp;(P&lt;0.001)</li>
 <li>LDL-C levels were reduced by&nbsp;39.2% ± 29.5%&nbsp;at&nbsp;3 months (P&lt;0.001)&nbsp;and by&nbsp;31.9% ±37.5%&nbsp;at&nbsp;6 months (P&lt;0.001)</li>
</ul>

<table border="1" cellpadding="10" cellspacing="1" style="width:1000%;">
 <tbody>
 <tr>
 <td>Only&nbsp;20.6%&nbsp;achieved the composite goal of LDL-C reduction ≥50% and levels &lt;55 mg/dL in accordance with 2019 ESC/EAS guidelines despite the significant observed reduction in LDL-C levels</td>
 </tr>
 </tbody>
</table>

<ul>
 <li>At target achievement assessment: 
 <ul>
 <li>62.6%&nbsp;of patients had achievedLDL-C level decrease ≥50%</li>
 <li>42.9%&nbsp;had LDL-C levels &lt;55 mg/dL</li>
 </ul></li>
</ul>

Proportion of patients on LLT:
<ul>
 <li>Only&nbsp;28.9%&nbsp;were takingstatins pre-ACS</li>
 <li>Only&nbsp;8.5%&nbsp;were prescribedother LLT at discharge</li>
</ul>
Patient perception about ACS:
<ul>
 <li>A large proportion of patients (43.7%) reported never worryingabout the risk of ACS recurrence</li>
 <li>68.6%&nbsp;do not associatehigh cholesterol levels withincreased risk of ACS</li>
</ul>
Majority of patients were prescribed high-intensity statins and LDL-C levelsdecreased consistently. However,&nbsp;57.1%&nbsp;of patients still had LDL-C levels &gt;55 mg/dL at LDL-C goal assessment

<h2>Limitations</h2>
<ul>
 <li>The small sample size does notrepresent the entire Saudi Arabianpost-ACS patients population</li>
 <li>No data were collected on dietary measures and lifestyle modifications implemented post-ACS to mitigate subsequent CV risks</li>
</ul>

<h2>Recommendation</h2>
<ul>
 <li>A prospective country-specific program is required to assess the current lipid management approaches and the scope of improvement</li>
</ul>

Prospective evaluation of lipid management following acute coronary syndrome in Saudi Arabia

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