INTEGRATED-DIABETES-CARE

DIABETES

Challenges associated with commonly-used insulin advancement options

An educational video to discuss the challenges associated with commonly-used insulin advancement options and the need for treatment simplification for many adults with T2D. The video reviews data supporting the use of BI + GLP-1 RA FRCs versus commonly-used insulin regimens in adults with T2D.

TYPE-2-DIABETES

ATTD 2021: Technology Supporting Initiation, Titration, and Intensification

Technology has significantly improved insulin therapy management in recent years, providing solutions for unmet needs and enhancing patient care. The integration of digital solutions and new technologies has resulted in continuous glucose monitoring with alerts and alarms, improving patient adherence and persistence, leading to better long-term health outcomes. Watch the video to learn more about the key thought leader interview with Dr. Halperin, following the ATTD 2021 Congress, covering the topic: Unmet needs in people with diabetes: technology supporting initiation, titration, and intensification.

ATTD 2021: Patients’ profiles for digital tools

Following the ATTD 2021 meeting, Professor Barnard was interviewed as a key thought leader who would mainly discuss points relevant to the topic 'Patient Profiles for Digital Tools: Exploring Habits and Barriers.' In this engaging conversation, Professor Barnard addresses critical aspects of patient profiles for digital tools, shedding light on the behaviors and challenges that need scrutiny. Drawing from extensive experience, she offers insights for healthcare professionals to better grasp patient preferences in using digital technologies for treatment. Professor Barnard also highlights common hurdles patients face and provides practical solutions to enhance patient outcomes.

Advancing Therapy with iGlarLixi: Differentiation from other complex regimens

An educational video outlining key data from indirect comparisons of iGlarLixi versus IDegAsp.

<h2>New Soliqua®*&nbsp;data shows improved blood sugar control without weight gain versus premixed insulin</h2>
<ul>
 <li>Study also shows more people on Soliqua had improved blood sugar control without weight gain and without low blood sugar events (hypoglycemia) in first head-to-head comparison with premixed insulin</li>
</ul>

<h3>June 28, 2021</h3>
A new study of Soliqua (insulin glargine 100 Units/mL and lixisenatide, iGlarLixi) met its two primary endpoints and all key secondary endpoints in a head-to-head comparison against premixed insulin (biphasic insulin aspart 30, BIAsp 30) in adults living with type 2 diabetes, the most common form of diabetes, uncontrolled on insulin and one or two oral anti-diabetic medicines. The findings were presented today at the American Diabetes Association (ADA) 81st Scientific Sessions1 and simultaneously published in Diabetes Care.2
The study met both primary endpoints with Soliqua demonstrating noninferiority of blood sugar (HbA1c) reduction and superiority on body weight change from baseline compared to premixed insulin. The study also met its key secondary endpoints with Soliqua achieving a greater proportion of people reaching a HbA1c target of &lt;7% without weight gain, a greater proportion of people reaching a HbA1c target of &lt;7% without weight gain and without hypoglycemia, and superiority in reduction of HbA1c compared with those using premixed insulin.
“Concerns about hypoglycemia and weight gain are known barriers when advancing basal insulin therapy, especially with complex insulin regimens,” says Julio Rosenstock, Director of the Dallas Diabetes Research Center at Medical City, Dallas, TX, and main author of the study. “These results show improved outcomes with iGlarLixi over BIAsp 30, demonstrating better glucose control without body weight gain and less hypoglycemia. This combined benefit could help clinicians consider advancing basal insulin therapy by switching to a once-daily fixed-ratio combination of basal insulin plus a GLP-1 receptor agonist rather than switching to a twice-daily premixed insulin regimen.”
A secondary analysis also found study participants using Soliqua reported greater improvements in patient-reported outcomes compared to premixed insulin as measured by Treatment-Related Impact Measure Diabetes (TRIM-D) and patient- and physician-rated Global Treatment Effectiveness Evaluation (GTEE) scores.3&nbsp;These tools include measurements of treatment burden, daily life, diabetes management, compliance, psychological health, and treatment effectiveness.
“While premixed is used by around 40% of people taking insulin globally to manage their type 2 diabetes today, recent real-world evidence suggests only 18.2% of people using it reach their blood sugar goal,”4,5 said Sandra Silvestri, M.D., Ph.D., Global Medical Head of General Medicines at Sanofi. “Today’s results provide further information on Soliqua’s impact and patient-reported outcomes that could be considered by healthcare providers in regions such as India, China, the Middle East and North Africa, where premix is widely used."
Safety findings were in line with the established profiles of Soliqua and premixed insulin.

<h2>About the SoliMix study</h2>
The SoliMix study was a 26-week, randomized controlled trial of 887 adults living with type 2 diabetes who were uncontrolled on insulin plus metformin with or without a sodium glucose cotransporter-2 inhibitor (SGLT-2i). The study compared the efficacy and safety of Soliqua compared to a commonly used premixed insulin (BIAsp 30). Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
The study met its two primary endpoints and all three of its key secondary endpoints.

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <th colspan="4" rowspan="1" style="background-color: rgb(244, 242, 246);">SoliMix Data Summary</th>
 </tr>
 <tr>
 <th colspan="2" style="background-color: rgb(244, 242, 246);">&nbsp;</th>
 <th colspan="1" style="background-color: rgb(244, 242, 246);">Soliqua 
 (n=443)</th>
 <th colspan="1" style="background-color: rgb(244, 242, 246);">Premixed Insulin (n=444)</th>
 </tr>
 <tr>
 <td rowspan="3">HbA1c, %</td>
 <td>Baseline</td>
 <td>8.61 ± 0.67</td>
 <td>8.57 ± 0.65</td>
 </tr>
 <tr>
 <td>LS mean change from baselineto Week 26 ± SE</td>
 <td>-1.30 ± 0.06</td>
 <td>-1.05 ± 0.06</td>
 </tr>
 <tr>
 <td>LS mean difference (97.5% CI)* 
 p-value for non-inferiority† 
 LS mean difference (95% CI)‡ 
 p-value for superiority§</td>
 <td colspan="2">-0.24 (-0.41, -0.08) 
 p&lt;0.001 
 -0.24 (-0.39, -0.10) 
 p&lt;0.001</td>
 </tr>
 <tr>
 <td rowspan="3">HbA1c, mmol/mol</td>
 <td>Baseline</td>
 <td>70.6 ± 7.3</td>
 <td>70.2 ± 7.1</td>
 </tr>
 <tr>
 <td>LS mean change from baselineto Week 26 ± SE</td>
 <td>-14.2 ± 0.7</td>
 <td>-11.5 ± 0.7</td>
 </tr>
 <tr>
 <td>LS mean difference (97.5% CI)* 
 p-value for non-inferiority† 
 LS mean difference (95% CI)‡ 
 p-value for superiority§</td>
 <td colspan="2">-2.6 (-4.5, -0.9) 
 p&lt;0.001 
 -2.6 (-4.3, -1.1) 
 p&lt;0.001</td>
 </tr>
 <tr>
 <td rowspan="3">Bodyweight, kg</td>
 <td>Baseline</td>
 <td>80.7 ± 16.5</td>
 <td>82.2 ± 18.5</td>
 </tr>
 <tr>
 <td>LS mean change from baselineto Week 26 ± SE</td>
 <td>-0.70 ± 0.20</td>
 <td>+1.15 ± 0.20</td>
 </tr>
 <tr>
 <td>LS mean difference (95% CI) 
 p-value for superiority*</td>
 <td colspan="2">-1.86 (-2.28, -1.43) 
 p&lt;0.001</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="2">HbA1c&lt;7 % without weight gain, n (%) 
 Odds ratio (95% CI)‡</td>
 <td>122 (27.5)</td>
 <td>55 (12.4)</td>
 </tr>
 <tr>
 <td colspan="2">2.83 (1.98, 4.04); p&lt;0.001</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="2">HbA1c&lt;7 % without weight gain and without hypoglycemia (plasma glucose&lt;70 mg/dL [&lt;3.9 mmol/L]), n (%) 
 Odds ratio (95% CI)‡</td>
 <td>86 (19.4)</td>
 <td>31 (7.0)</td>
 </tr>
 <tr>
 <td colspan="2">3.40 (2.19, 5.28); p&lt;0.001</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="2">HbA1c&lt;7 %, n (%)§ 
 Odds ratio (95% CI)</td>
 <td>187 (42.2)</td>
 <td>141 (31.8)</td>
 </tr>
 <tr>
 <td colspan="2">1.65 (1.25, 2.19)</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="1">Incidence and rates of hypoglycemia (safety population)</td>
 <td>n=442 
 223.15 PY</td>
 <td>n=441 
 217.85 PY</td>
 </tr>
 <tr>
 <td colspan="4">Level 1 (ADA definition: &lt;70 mg/dL [&lt;3.9 mmol/L] and ≥54 mg/dL [≥3.0 mmol/L])</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="4">n (%) 
 Odds ratio (95% CI) 
 PPY (events) 
 Rate ratio (95% CI)</td>
 <td>114 (25.8)</td>
 <td>170 (38.5)</td>
 </tr>
 <tr>
 <td colspan="2">0.55 (0.42, 0.74)</td>
 </tr>
 <tr>
 <td>2.03 (453)</td>
 <td>2.83 (616)</td>
 </tr>
 <tr>
 <td colspan="2">0.71 (0.52, 0.99)</td>
 </tr>
 <tr>
 <td colspan="4">Level 2 (ADA definition: &lt;54 mg/dL [&lt;3.0 mmol/L])</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="4">n (%) 
 Odds ratio (95% CI) 
 PPY (events) 
 Rate ratio (95% CI)</td>
 <td>28 (6.3)</td>
 <td>57 (12.9)</td>
 </tr>
 <tr>
 <td colspan="2">0.45 (0.28, 0.73)</td>
 </tr>
 <tr>
 <td>0.25 (56)</td>
 <td>0.56 (121)</td>
 </tr>
 <tr>
 <td colspan="2">0.40 (0.23, 0.71)</td>
 </tr>
 <tr>
 <td colspan="4">Level 3 ADA definition: severe hypoglycemia)¶</td>
 </tr>
 <tr>
 <td colspan="2" rowspan="4">n (%) 
 Odds ratio (95% CI) 
 PPY (events) 
 Rate ratio (95% CI)</td>
 <td>1 (0.2)</td>
 <td>2 (0.5)</td>
 </tr>
 <tr>
 <td colspan="2">0.50 (0.04, 5.56)</td>
 </tr>
 <tr>
 <td>0 (1)</td>
 <td>0.01 (2)</td>
 </tr>
 <tr>
 <td colspan="2">0.49 (0.04, 5.40)</td>
 </tr>
 </tbody>
</table>

Data shown are mean ± SD unless otherwise specified. *Primary endpoint was assessed at 0.025 for non-inferiority on HbA1c change from baseline then 0.05 for other endpoints, as the alpha was distributed to subsequent tests. †Two primary efficacy endpoints, non-inferiority of HbA1c reduction assessed using a margin of 0.3 %; ‡Secondary endpoint was assessed at the alpha 0.05 level. §Secondary endpoint. ¶A hypoglycemic event with severe cognitive impairment (hypoglycemic unconsciousness) requiring external assistance for recovery. 
 ADA, American Diabetes Association; AE, adverse event; BiAsp, biphasic aspart insulin; BMI, body mass index; CI, confidence interval; iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and the glucagon-like peptide-1 receptor agonist, lixisenatide; ITT, intent to treat population; LS, least squares; PPY, per participant-year; PY, participant-year; SD, standard deviation; SE, standard error; T2D, type 2 diabetes.
In a secondary analysis, participants using Soliqua also reported greater improvements in patient-reported outcomes as measured by TRIM-D and patient- and physician-rated GTEE scores at 26 weeks.
<ul>
 <li>TRIM-D results demonstrated greater improvements for participants using Soliqua compared to those using premixed insulin, across domains including compliance, diabetes management, and psychological health, among others.3</li>
 <li>GTEE findings showed that nearly twice as many patients reported complete control of their diabetes with Soliqua compared to premixed insulin (27.5% vs 15%). Similarly, nearly twice as many physicians also reported treatment effectiveness (i.e., complete control of diabetes) with Soliqua compared to premixed insulin (29.9% vs 15.3%).3</li>
</ul>
Safety findings were in line with the established profiles of both treatments. The most commonly reported adverse events in the study were hypoglycemia (31.2% Soliqua, 42.4% premixed insulin), nausea (7.7% Soliqua, 0% premixed insulin), headache (2.5% Soliqua, 0.5% premixed insulin), dizziness (1.4% Soliqua, 0.5% premixed insulin), and vomiting (1.1% Soliqua, 0.2% premixed insulin).

* Soliqua®&nbsp;is an injectable prescription medicine that contains two diabetes medicines, insulin glargine and lixisenatide. Soliqua®&nbsp;is marketed in the EU as Suliqua®, where it is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin. It is marketed in the U.S. as Soliqua® 100/33, where it is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is marketed as Soliqua®&nbsp;in other geographies where it is approved.

References

ADA 2021: Solimix Trial Summary

SoliMix Study Results Summary

Discover clinical outcomes with iGlarLixi versus Premix BIAsp 30 in the SoliMix Randomized Controlled Trial leading to advancing therapy in sub-optimally controlled basal insulin-treated Type-2 diabetes.

<h2 style="text-align: center;">WHY TO SCREEN</h2>
Proactive screening reduces the likelihood of a medical emergency and enables a smoother transition to life with Stage 3 autoimmune T1D.7,8,27,28

<h2>SCREENING AND MONITORING PROGRAMMES CAN REDUCE RATES OF DKA BY UP TO APPROXIMATELY 90%, PREVENTING SEVERE COMPLICATIONS AND REDUCING HOSPITALISATION27</h2>
Studies show that screening can lower rates of DKA at onset of Stage 3 autoimmune T1D.34–40 
 High reductions of DKA rates were observed in the following studies:

DKA, diabetic ketoacidosis; HLA, human leukocyte antigen; T1D, type 1 diabetes; TEDDY, The Environmental Determinants of Diabetes in the Young; US, United States. *Public health screening that screened 90,632 children for autoimmune T1D islet autoantibodies in Bavaria, Germany, of the 62 children with presymptomatic autoimmune T1D who developed Stage 3 of the condition, 2 (3.2%) were diagnosed in the laboratory with mild or moderate DKA without clinical symptoms, while 60 (96.8%) did not have DKA.34&nbsp; †The previously reported prevalence of DKA in unscreened children is over 20% in Germany.34 
 ‡A study that screened 424,788 children for autoimmune T1D HLA risk at birth and enrolled 8,677 children between 2004 and 2010. Of those children aged &lt;5 years at autoimmune T1D diagnosis, 9 of 79 (11%) experienced DKA at diagnosis.35

<h2>ENABLE A SMOOTHER TRANSITION INTO LIFE WITH AUTOIMMUNE T1D7,8,27,28,47,48</h2>
An abrupt Stage 3 autoimmune T1D diagnosis can feel like a crash-landing for individuals and their families.49,50

TIME TO PREPARE

LESS DISTRESS

A SMOOTHER TRANSITION

FAMILY EDUCATION

TYPE-1-DIABETES

DKA, diabetic ketoacidosis; T1D, type 1 diabetes. *Diabetes distress refers to the emotional burden and stress resulting from the ongoing demands of managing diabetes daily.51 †Qualitative studies reveal that while maternal anxiety levels initially spike after learning of their child’s high-risk status, this anxiety typically subsides to normal levels within 4–12 months.48

Why to screen for Autoimmune T1D

Unveiling Significance of Time in Range: Value as key Glycemic Biomarker

Join Dr. Battelino as he explores the crucial role of ‘Time in Range’ as a glycemic biomarker, illuminating its value in diabetes management and overall health outcomes. This insightful discussion offers a comprehensive understanding of this key metric in diabetes care. Don’t miss out on this opportunity to enhance your knowledge and improve patient care.

<h2>Beyond HbA1C, It is time to think Time-in-Range</h2>

<h3>Glycemic variability is a common challenge for people with diabetes and has a range of serious consequences1- 9</h3>
It is known today that two people with identical HbA1c&nbsp;level of 8.0% can have&nbsp;markedly different degrees of glycemic variability10*

<h3>Beyond HbA1c, rise of Time-in-Range as a new key metric for Glycemic control</h3>

Evaluating TIR can aid understanding&nbsp;whether hypoglycemia (time-below-range) or hyperglycemia (time-above-range) are improving with treatment over time12,13

As per the latest International Consensus on Time-in-Range,&nbsp;TIR is identified as a metric of glycemic control that provides&nbsp;more actionable information than HbA1C&nbsp;alone11

<h3>Optimizing HbA1c&nbsp;to &lt;7.0%12,14&nbsp;and reducing Glycemic variability: TIR&gt;70% and %CV≤36%6,12,13&nbsp;helps achieve better patient outcomes9,13-16</h3>

Which Time-in-Range target should you aim for?
International guidelines recommend&nbsp;a target of&gt;70% TIR&nbsp;(70-80 mg/dL) for most adult patients with T1DM or T2DM11,13†

<h4>Optimizing Time-in-Range</h4>
<ul>
 <li>A fundamental aspect to effective diabetes management11</li>
</ul>

*15-day glucose traces of two patients who had identical HbA1c of 8.0% but different degrees of GV. High GV in patient 1 was reflected by numerous episodes of both hypo- and hyper- glycemia, whereas low GV in patient 2 resulted in no such episodes.1

†It is recommended that most adult patients spend &lt;1 hour per day with blood glucose &lt;70 mg/dL (&lt;3.9 mmol/L); &lt;15 minutes per day with blood glucose &lt;54 mg/dL (&lt;3.0 mmol/L); &lt;1 hour 12 minutes per day with blood glucose &gt;250 mg/dL (&gt;13.9 mmol/L); and &lt;6 hours per day with blood glucose &gt;180 mg/dL (&gt;10.0 mmol/L), although CGM-based targets vary for different diabetes populations. For people with T1DM aged &lt;25 years, if the HbA1c&nbsp;goal is 7.5%, then the TIR target should be set to approximately 60%. For older patients or those at high risk, the TIR target is 50% although individualized decision making is recommended. There is insufficient data to allow recommendation of TIR target for pregnant women.11,13

# Includes percentage of values &lt;54 mg/dL (3.0 mmol/L).11
**Includes percentage of values &gt;250 mg/dL (13.9 mmol/L).11

Abbreviations

Understanding Time-in-Range: Assessment, Targets, and Benefits for Optimal Glycemic Control

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