<h2>EARLY PRE-SYMPTOMATIC STAGES OF AUTOIMMUNE T1D CAN BE IDENTIFIED THROUGH TESTING FOR AUTOANTIBODIES AND MONITORING FOR DYSGLYCAEMIA61,64</h2>

ADA, American Diabetes Association; GAD-65, glutamic acid decarboxylase 65; IAA, insulin autoantibodies; IA-2A, insulinoma-associated antigen-2; T1D, type 1 diabetes; ZnT8A, zinc transporter 8.

<h2>AUTOIMMUNE T1D SCREENING RESULTS EXPLAINED</h2>
Early presymptomatic stages of autoimmune T1D can be identified through testing for autoantibodies in the blood.7,52

T1D, type 1 diabetes. *Reversion to single autoantibody or negative status can occur at Stage 2 in some people with previously confirmed multiple autoantibody positivity.4 †Recent Breakthrough T1D consensus guidance noted that some people revert to single autoantibody status in Stage 3.4

References

How to screen for Autoimmune T1D

TYPE-1-DIABETES

DIABETES

TYPE-2-DIABETES

Groundbreaking SoliD Study: Comparative Efficacy of iGlarLixi and IDegAsp

Uncover the findings of the SoliD study which compared the efficacy and safety of iGlarLixi and IDegAsp in 582 adults with uncontrolled type 2 diabetes (HbA1c: ≥7 to ≤11%) on metformin, with or without an SGLT2 inhibitor. This pioneering study revealed that iGlarLixi achieved superior HbA1c reduction and significant weight loss over 24 weeks. Learn about this unique study and the pivotal findings that could shape future diabetes management.

INTEGRATED-DIABETES-CARE

Connectivity Canvas: Pioneering Diabetes Management with Connected Insulin Caps

Discover how connected insulin caps are reshaping the landscape of diabetes management. This video offers a comprehensive overview of this cutting-edge technology, providing essential insights for healthcare professionals aiming to improve patient care and outcomes. Embark on this journey of technological progression in diabetes care.

An Evidence about The Role of Basal Insulin Glargine 300 U/mL Post-GLP-1 Therapy

Dr. Ritzzel discusses the efficacy of Glar300 in individuals inadequately controlled on GLP-1 RA. This engaging talk provides a deep understanding of how Glar300 can enhance diabetes management and improve patient outcomes. Don’t miss out on this opportunity to enhance your understanding and improve patient outcomes.

This session provided insights from the scientific statement put forward by the National Lipid Association on genetic testing in dyslipidemia, published in 2020; the statement paper discusses mainly the applications of genetic testing in patients with dyslipidemias and laboratory methods; technical, biological, clinical, and ethical implications.

<h2>Key Takeaway</h2>
<ul>
 <li>Genetic testing is increasingly becoming a common consideration in the clinical care of patients with dyslipidemia.</li>
 <li>Dyslipidemias for which genetic testing could be clinically useful include FH and other monogenic and polygenic lipid disorders</li>
 <li>Confirming a diagnosis of monogenic dyslipidemia using genetic testing can affect management and screening to identify affected family members, termed “cascade screening”, for example, as has been well defined in FH.</li>
 <li>Other potential benefits of genetic testing include guiding optimal management and prevention strategies, advancing care strategies beyond currently available treatments, identi¬fying affected family members, and contributing to scientific progress*.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>Genetic testing can help diagnosing dyslipidemias with underlying DNA mutations (variants).</li>
 <li>However, clinical indications for genetic testing for most dyslipidemias are not clearly established and currently no guidelines exist.</li>
</ul>

<h2>Key Results</h2>
What are monogenic and polygenic dyslipidemias? Monogenic dyslipidemias:
<ul>
 <li>Rare, large-effect DNA variants (mutations) that cause monogenic/Mendelian dyslipidemias, with FH being the most common Polygenic dyslipidemias:</li>
</ul>
Polygenic dyslipidemias:
<ul>
 <li>Result from concurrent contributions of multiple common variants whose aggregate effect on lipoprotein levels can resemble large-effect rare variant</li>
 <li>Inheritance does not follow Mendelian rules</li>
 <li>Impact of such common variant is quantified using a polygenic score</li>
 <li>Clinical utility of polygenic score is not clear</li>
</ul>
What are the potential indications for genetic testing in dyslipidemia?
<ul>
 <li>Strong clinical suspicion of a genetic dyslipidemia</li>
 <li>Strong family history of dyslipidemia or its complications</li>
 <li>Presence of related syndromic features</li>
 <li>Evidence that testing might change the management</li>
 <li>Existence of available and effective early interventions</li>
 <li>Eligibility for new or investigational drugs</li>
 <li>Patient preference</li>
 <li>Family planning</li>
 <li>Other indications, including different therapies depending on results, access to specialized therapies, and insurance coverage</li>
</ul>
What are the potential outcomes of genetic testing in dyslipidemia?
<ul>
 <li>Aid in clinical diagnosis and targeted treatment of specific disorders</li>
 <li>Guide optimal management and prevention strategies</li>
 <li>Increase patient compliance and motivation</li>
 <li>Provide early identification of affected family members through cascade screening</li>
 <li>Contribute to scientific advancement</li>
 <li>Indication for access to novel therapies</li>
 <li>Eligibility for insurance coverage for certain therapies</li>
</ul>
What should be considered while planning genetic testing?
<ul>
 <li>Intensity of FH treatment should be guided by LDL-C elevation rather than the underlying genotype</li>
 <li>Not all genetic tests are created equal</li>
 <li>Review analytic and clinical validity of a test prior to medical management decisions</li>
 <li>Attributing pathogenicity to a DNA variant can differ between laboratories</li>
 <li>Confirmation using clinical genetic test is recommended to avoid false-positive/false-negative results by direct-to-consumer genetic testing</li>
 <li>Polygenic scores for dyslipidemia are not standardized and not recommended or appropriate for clinical use in dyslipidemia</li>
</ul>
What are the components of genetic counselling? 
 Genetic counselling is offered to patients and their families before and after genetic testing.
Before ordering a genetic test:
<ul>
 <li>Obtain an informed consent form</li>
 <li>Counsel the patient regarding the risk and benefits of genetic testing After ordering a genetic test:</li>
</ul>
After ordering a genetic test:
<ul>
 <li>Test results should be disclosed by a clinician with expertise in genetics or by a certified genetic counselor</li>
 <li>Genetic counselling should be provided to patients and their families even if the results are negative</li>
 <li>Definitive incidental findings in certain genes that are unrelated to lipids should also be communicated to the patients</li>
 <li>Results should be tailored to the patient-specific circumstances, level of understanding, and literacy</li>
</ul>
<a href="https://www.lipid.org/nla/genetic-testing-dyslipidemia" target="_blank">*Infographic</a>

Abbreviations

Reference

Role of Genetic Testing in Management of Dyslipidemia

DYSLIPIDEMIA

CARDIOLOGY

<h2>Key takeaway</h2>
In this real-world survey of physicians and their patients with T2DM:
<ul>
 <li>A total of&nbsp;60.9% of patients&nbsp;did not achieve their HbA1c goal of 6.8% set by their physicians, with a&nbsp;mean distance of 0.9% from the goal.</li>
 <li>Physicians tended to&nbsp;wait before changing/adding pharmacologic agents&nbsp;until HbA1c was progressively higher (&gt;8%), suggesting&nbsp;therapeutic inertia.</li>
 <li>Patients&nbsp;aware of their HbA1c goal&nbsp;had slightly&nbsp;greater adherence&nbsp;to antihyperglycemic medication; however, goal awareness did not enhance goal attainment.</li>
</ul>
A holistic diabetes management approach, involving patient education, and patient–physician communication and partnership is needed.

<h2>Why this matters</h2>
<ul>
 <li>Guidelines recommend HbA1c targets of &lt;7% for most of the patients. 
 <ul>
 <li>However, in real-world clinical practice, individualized HbA1c goals can vary, and may be unattained.</li>
 </ul></li>
</ul>

<ul>
 <li>Patients’ knowledge of their individualized glycemic goal, its achievement and distance, and the HbA1c level for treatment intensification are not well understood.</li>
</ul>

<h2>Study design</h2>
Data was drawn from the Adelphi Diabetes Disease Specific ProgrammeTM&nbsp;and collected in Germany, Italy, Spain, UK, and USA between October 2018 and March 2019.
<h3>Patient Enrolment and Eligibility Criteria</h3>
<ul>
 <li>Participating physicians enrolled the next 10 consulting patients with T2DM meeting the following eligibility criteria: 
 <ul>
 <li>Patients ≥18 years of age, not in a clinical trial, receiving ≥1 AHA</li>
 </ul></li>
</ul>
<ul>
 <li>2 additional patients treated with either a SGLT2i or a GLP-1 RA, or both*</li>
</ul>
<h3>Survey Questionnaires</h3>
<ul>
 <li>Physicians:&nbsp;Patient demographics, tests performed, HbA1c goal, comorbid conditions, and current and previous treatment including HbA1c at initiation</li>
</ul>
<ul>
 <li>Patients:&nbsp;Demographics and current condition; information on medication adherence using the ARMS-D; awareness of HbA1c goal (sub-analysis assessment)</li>
</ul>
<h3>Patient Inclusion Criteria</h3>
Diagnosed for ≥3 months with T2DM and had physician-reported current and target HbA1c

<h2>Key results</h2>
A total of 730 physicians (primary care physicians: 58%; diabetologists/ endocrinologists: 42%) provided data on 5,331 eligible patients with T2DM.
<h3>Patient Details</h3>
<table border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Patient parameters</td>
 <td style="background-color: rgb(244, 242, 246);">Proportion of patients</td>
 </tr>
 <tr>
 <td>Males / Females</td>
 <td>55.0% / 45.0%</td>
 </tr>
 <tr>
 <td>Median (IQR) duration of Diabetes</td>
 <td>4.7 (2.0–9.6) years</td>
 </tr>
 <tr>
 <td>Mean (SD) individualized HbA1c goal</td>
 <td>6.8% (0.7%)</td>
 </tr>
 <tr>
 <td>Attainment of HbA1c goal</td>
 <td>39.1%</td>
 </tr>
 <tr>
 <td>Mean Distance (SD) from individualized HbA1c goal†</td>
 <td>0.9% (1.0%)</td>
 </tr>
 <tr>
 <td>
 Patients’ HbA1c for progression of Antihyperglycemic therapy</td>
 <td>&gt;8%</td>
 </tr>
 </tbody>
</table>
Sub-Analysis
Of 5,331 patients included, 48.0% patients qualified for the sub-analysis.
<ul>
 <li>70.5% patients were aware of their HbA1c goal 
 <ul>
 <li>However, only 39.2% patients were successful in achieving their goal.</li>
 </ul></li>
</ul>

<ul>
 <li>Achieving HbA1c goal had no relation to knowledge of goal.</li>
 <li>Physicians were not satisfied with the current blood glucose level of about one third of the patients.</li>
</ul>
Physicians were more satisfied with the current blood glucose level of patients aware of their HbA1c goal in the sub-analysis vs the excluded patients not aware of their HbA1c goal (58.4% vs. 49.0% [P &lt;0.0001])

<h3>Patients aware vs unaware of their HbA1c goals</h3>
<table border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(244, 242, 246); width: 35%;">Parameters assessed</td>
 <td style="background-color: rgb(244, 242, 246); width: 25%;">Patients aware of goal (n = 1,804)</td>
 <td style="background-color: rgb(244, 242, 246); width: 25%;">Patients unaware of goal (n = 746)</td>
 <td style="background-color: rgb(244, 242, 246); width: 15%;">P value</td>
 </tr>
 <tr>
 <td style="width: 35%;">Achievement of HbA1c goal</td>
 <td style="width: 25%;">38.2%</td>
 <td style="width: 25%;">41.4%</td>
 <td style="width: 15%;">P = 0.143</td>
 </tr>
 <tr>
 <td style="width: 35%;">Adherence to AHAs (ARMS-D total score)</td>
 <td style="width: 25%;">14.8</td>
 <td style="width: 25%;">15.5</td>
 <td style="width: 15%;">P &lt;0.0001</td>
 </tr>
 <tr>
 <td style="width: 35%;">Prescription of more AHAs</td>
 <td style="width: 25%;">68.4%</td>
 <td style="width: 25%;">55.0%</td>
 <td style="width: 15%;">P &lt;0.0001</td>
 </tr>
 <tr>
 <td style="width: 35%;">Patients on second- or later line of therapy</td>
 <td style="width: 25%;">53.3%</td>
 <td style="width: 25%;">44.8%</td>
 <td style="width: 15%;">NA</td>
 </tr>
 <tr>
 <td style="width: 35%;">Likely to test blood glucose levels</td>
 <td style="width: 25%;">74.1%</td>
 <td style="width: 25%;">54.6%</td>
 <td style="width: 15%;">P &lt;0.0001</td>
 </tr>
 <tr>
 <td style="width: 35%;">Physicians’ belief of better glucose control achievement</td>
 <td style="width: 25%;">34.2%</td>
 <td style="width: 25%;">28.2%</td>
 <td style="width: 15%;">P = 0.003</td>
 </tr>
 </tbody>
</table>

<h2>Key limitations</h2>
<ul>
 <li>Non-random sample of physicians caused over-representation of specialists.</li>
 <li>Potential differences between physicians’ knowledge level and diabetes management might have affected patient treatment and clinical outcomes.</li>
 <li>Patient population was not truly random due to the inclusion of next 10 consecutive consulting patients, and 2 additional patients on&nbsp;SGLT2i/GLP-1&nbsp;RA&nbsp;therapy.</li>
 <li>Analysis excluded 39.4% of patients with no current&nbsp;HbA1c/individualized&nbsp;HbA1c&nbsp;goals, or those with&nbsp;T2DM&nbsp;for &lt;3 months.</li>
 <li>Study findings might have been affected by country variations in clinical practice.</li>
</ul>
* Either alone or in combination with other&nbsp;AHAs 
 † Among those patients not reaching their individualized HbA1c goal

Patient awareness and attainment of goals in Type 2 Diabetes Mellitus: A real-world survey

<h2>Key takeaway</h2>
This narrative literature review exploring the&nbsp;insulin subtypes&nbsp;likely to&nbsp;prevent hypoglycemia&nbsp;and&nbsp;reduce hyperglycemia&nbsp;in patients with insulin dependent T2D when&nbsp;fasting during Ramadan&nbsp;found that: 
 &nbsp;
<ul>
 <li>Long-acting insulins&nbsp;were&nbsp;safe&nbsp;and&nbsp;reduced the risk of hypoglycemia&nbsp;vs intermediate-acting insulins</li>
 <li>Rapid-acting insulin analogs reduced post-iftar hyperglycemia&nbsp;more than regular human insulin</li>
 <li>Using&nbsp;flexible glycemic targets improved outcomes&nbsp;after fasting season</li>
</ul>
Overall, these findings should not be generalized, and each&nbsp;patient’s specific insulin regimen should be evaluated&nbsp;before the Ramadan fasting month.*

<h2>Why this matter</h2>
<ul>
 <li>Muslims with insulin dependent T2D are highly&nbsp;at risk for developing AEs while fasting&nbsp;for periods of up to 20 hours&nbsp;during Ramadan.</li>
 <li>Most&nbsp;physicians may have insufficient practical&nbsp;knowledge&nbsp;to appropriately manage insulin dependent T2D during Ramadan.</li>
</ul>
Determining&nbsp;effective and safe methods&nbsp;for Muslim patients with diabetes to fast during Ramadan is&nbsp;critical.

<h2>Study design</h2>
<ul>
 <li>Eligible studies were identified from PubMed, Medline, and EMBASE databases in June 2021.</li>
 <li>Only primary studies on non-pregnant adult patients with insulin dependent T2D fasting during Ramadan, published in the last 20 years, were included.</li>
</ul>

<h2>Key results</h2>
A total of&nbsp;10 studies&nbsp;with&nbsp;6–493 patients&nbsp;were included in this review.
<ul>
 <li>4 prospective, observational studies on various treatment strategies</li>
 <li>6 open-label, comparison studies of 2 different treatment strategies, including 3 RCTs</li>
</ul>
<table align="center" border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(244, 242, 246); width: 20%;">Study</td>
 <td style="background-color: rgb(244, 242, 246); width: 40%;">Reduction in hypoglycemic events</td>
 <td style="background-color: rgb(244, 242, 246); width: 40%;">Improvement in hyperglycemic events</td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://onlinelibrary.wiley.com/doi/10.1111/ijcp.12695" target="_blank">Shehaded et al.</a></td>
 <td style="width: 40%;">Long-acting morning insulin + shorter-acting, biphasic insulin&nbsp;significantly lowered AE rates, especially rates of hypoglycemia vs twice-daily dosing of intermediate-acting insulin</td>
 <td style="width: 40%;">No improvements in hyperglycemia</td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://www.sciencedirect.com/science/article/pii/S016882271731598X?via%3Dihub">Hassanein et al. 2018</a></td>
 <td style="width: 40%;">
 <ul>
 <li>Ultra-long acting + short acting insulin&nbsp;vs short- and intermediate-acting insulin reduced: 
 <ul>
 <li>Overall hypoglycemia by&nbsp;74%</li>
 <li>Nocturnal hypoglycemia by&nbsp;83%</li>
 </ul></li>
 </ul></td>
 <td style="width: 40%;">
 <ul>
 <li>Combination of ultra-long acting + short-acting insulin&nbsp;vs short + intermediate-acting insulin: 
 <ul>
 <li>Lowered pre-iftar glucose&nbsp;readings during Ramadan&nbsp;</li>
 <li>No difference was seen in post-Ramadan HbA1c nor in self-measured plasma glucose time points</li>
 </ul></li>
 </ul></td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://journals.lww.com/indjem/Fulltext/2016/20040/Insulin_degludec_and_insulin_degludec_insulin.24.aspx" target="_blank">Kalra et al.</a></td>
 <td style="width: 40%;">No hypoglycemic events were seen with&nbsp;ultra-long acting + shortacting insulin&nbsp;(n = 6)</td>
 <td style="width: 40%;">No statistically significant difference in hyperglycemia</td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://scholar.ui.ac.id/en/publications/a-multicenter-prospective-non-interventional-evaluation-of-effica" target="_blank">Soewondo et al.</a></td>
 <td style="width: 40%;">Reduction of daytime and nocturnal hypoglycemia (without reaching significance) seen with a mixture of&nbsp;short-and intermediate-acting insulin&nbsp;vs pre-therapy</td>
 <td style="width: 40%;">Short + intermediate-acting insulin&nbsp;lowered HbA1c</td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://linkinghub.elsevier.com/retrieve/pii/S0168822720304393" target="_blank">Hassanein et al. 2020</a></td>
 <td style="width: 40%;">No severe hypoglycemic events were seen&nbsp;with a secondgeneration long-acting basal insulin&nbsp;analog (n = 493)</td>
 <td style="width: 40%;">
 <ul>
 <li>Long-acting insulin:
 <ul>
 <li>Improved fasting BG from 8.0 to 7.1 mmol/L&nbsp;</li>
 <li>Lowered&nbsp;HbA1c from 8.1% to 7.6%</li>
 </ul></li>
 </ul></td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://linkinghub.elsevier.com/retrieve/pii/S0168822720304848">Ahmedani et al.</a></td>
 <td style="width: 40%;">A&nbsp;0.6% rate of hypoglycemia&nbsp;(6 events total) was seen in a prospective study of glycemic targets</td>
 <td style="width: 40%;">Use of flexible glycemic target during fasting&nbsp;daytime hours (11.1 mmol/L) and&nbsp;tighter targets during the night&nbsp;(10.0 mmol/L) significantly reduced&nbsp;HbA1c from 9.2% to 8.3%&nbsp;(P &lt;0.0001)</td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://onlinelibrary.wiley.com/doi/10.1111/j.1742-1241.2010.02347.x" target="_blank">Hui et al.</a></td>
 <td style="width: 40%;">No significant differences in hypoglycemia between study groups</td>
 <td style="width: 40%;">
 <ul>
 <li>Mixture of fast-acting + intermediate-acting insulins&nbsp;lowered HbA1c by&nbsp;0.48%</li>
 <li>Mixture of intermediate + shortacting insulin increased HbA1c by 0.28%</li>
 </ul></td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://www.sciencedirect.com/science/article/pii/S0168822702002024?via%3Dihub" target="_blank">Mattoo et al.</a></td>
 <td style="width: 40%;">No significant differences in hypoglycemia between study groups</td>
 <td style="width: 40%;">Combination of&nbsp;fast-acting + intermediate-acting insulins&nbsp;lowered&nbsp;pre-iftar&nbsp;and&nbsp;2-hour post-iftar&nbsp;glucose vs combination of intermediate + short-acting insulin</td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13348" target="_blank">Hajjaji et al.</a></td>
 <td style="width: 40%;">No significant differences in hypoglycemia between study groups</td>
 <td style="width: 40%;">
 <ul>
 <li>Mixture of&nbsp;fast-acting + intermediate-acting insulins&nbsp;(at 2 different concentrations: 50:50 at iftar and 25:75 at suhur) (n = 20) lowered:</li>
 <li>Postprandial plasma glucose&nbsp;by 1.2 mmol/L</li>
 <li>HbA1c by 0.4%&nbsp;vs mixture of intermediate + short-acting insulin (n = 20)</li>
 </ul></td>
 </tr>
 <tr>
 <td style="width: 20%;"><a href="https://www.cureus.com/articles/45688-comparison-of-human-premixed-and-basal-plus-short-acting-insulin-regimens-for-individuals-with-type-2-diabetes-during-ramadan-fasting" target="_blank">Altemimi et al.</a></td>
 <td style="width: 40%;">No significant differences in hypoglycemia between study groups</td>
 <td style="width: 40%;">No significant difference in HbA1c</td>
 </tr>
 </tbody>
</table>
For information on statistical significance, please click on the hyperlinks to see the article full-texts.

<h2>Limitations</h2>
<ul>
 <li>Three large databases were searched to identify relevant studies in a non-systematic manner and the results were not exhaustive.</li>
 <li>The risk of bias was not analyzed in each individual study, which limits the strength of the overall evidence.</li>
</ul>
For additional details, please refer to the source publication&nbsp;<a href="https://pubmed.ncbi.nlm.nih.gov/35585815/" target="_blank">Kieu A, et al.</a> 
 * An updated comprehensive systematic review including a critical appraisal of each included study is necessary to identify strategies to improve clinical care of patients with insulin dependent T2D during Ramadan.

A narrative review for clinicians on insulin management for Type 2 Diabetes during Ramadan

<h2>Advancing therapy in Suboptimallycontrolled Basal insulin-treated Type 2 Diabetes: Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial</h2>
<h3>Introduction</h3>
<ul>
 <li>For people with&nbsp;T2D&nbsp;on basal insulin who fail to reach their recommended glycemic targets, options for treatment advancement include: 
 <ul>
 <li>Basal insulin + progressive addition of rapid-acting insulin</li>
 <li>Premix insulin</li>
 <li>Basal insulin +&nbsp;GLP-1 RA</li>
 <li>Fixed-ratio combination (FRC) of basal insulin +&nbsp;GLP-1 RA</li>
 </ul></li>
 <li>All these treatment options have been shown to improve glycemic control when used to advance therapy from basal insulin, but are associated with specific side-effects: 
 <ul>
 <li>GLP-1 RA&nbsp;therapy can be associated with gastrointestinal&nbsp;AEs&nbsp;and resultant adherence issues</li>
 <li>Basal + rapid-acting insulin and premix insulin regimens can increase the risk of hypoglycemia and weight gain, require multiple daily injections and frequent glucose monitoring</li>
 </ul></li>
 <li>Globally, premix insulins are widely used to advance insulin therapy from basal insulin</li>
 <li>iGlarLixi&nbsp;is a once-daily titratable&nbsp;FRC&nbsp;of basal insulin glargine 100 U/mL (iGlar) and the&nbsp;GLP-1 RA, lixisenatide (Lixi), which offers an alternative option to premix insulin for treatment advancement</li>
</ul>
<h3>Objective</h3>
SoliMix is the first&nbsp;RCT&nbsp;to directly compare the efficacy and safety of an&nbsp;FRC&nbsp;of basal insulin and&nbsp;GLP-1&nbsp;RA,&nbsp;iGlarLixi, with premix insulin analog, biphasic insulin aspart 30 (BIAsp 30), in people with&nbsp;T2D&nbsp;advancing from basal insulin plus one or two&nbsp;OADs
<h3>Methods</h3>
<h4>Population</h4>
<ul>
 <li>Adults (≥18 years)</li>
 <li>Suboptimally controlled by basal insulin combined with metformin ± SGLT2i</li>
 <li>HbA1c of ≥7.5 % and ≤10.0 % (≥58.5–≤85.8 mmol/mol)</li>
</ul>

Detailed methods have been previously published¹
<table border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td>&nbsp;</td>
 <td>Mean ± SD 
 age, years</td>
 <td>
 Sex, 
 % female</td>
 <td>Mean ± SD 
 BMI, kg/m2</td>
 <td>Mean ± SD 
 duration of 
 T2D, years</td>
 <td colspan="2">Mean ± SD 
 HbA1c</td>
 </tr>
 <tr>
 <td colspan="5" rowspan="1" style="text-align: right;">%</td>
 <td colspan="2" rowspan="1">mmol/mol</td>
 </tr>
 <tr>
 <td>iGlarLixi 
 (n=443)</td>
 <td>59.8 
 ±10.3</td>
 <td>49.4%</td>
 <td>29.7 
 ±4.7</td>
 <td>13.0 
 ±7.1</td>
 <td>8.6 
 ±0.7</td>
 <td>71 
 ±7</td>
 </tr>
 <tr>
 <td>BIAsp 30 
 (n=444)</td>
 <td>59.8 
 ±10.0</td>
 <td>50.9%</td>
 <td>30.0 
 ±5.1</td>
 <td>13.0 
 ±7.4</td>
 <td>8.6 
 ±0.7</td>
 <td>70 
 ±7</td>
 </tr>
 </tbody>
</table>
Further details on baseline characteristics have been pr eviously published1
<h3>Key results: Efficacy</h3>
Both primary efficacy endpoints were met:&nbsp;iGlarLixi, demonstrated non-inferiority in HbA1c&nbsp;reduction and superiority in bodyweight change from baseline to Week 26 versus&nbsp;BIAsp 30&nbsp;(ITT population). Secondary analyses showed iGlarLixi was superior to&nbsp;BIAsp 30&nbsp;in HbA1c&nbsp;reduction.
iGlarLixi(n=443)
LS&nbsp;mean ±&nbsp;SE&nbsp;change in&nbsp;HbA1c&nbsp;from baseline to Week 26, %

VS
BIAsp 30&nbsp;(n=444)
LS mean ± SE change in bodyweight from baseline to Week 26, kg

<h3>Secondary efficacy endpoints</h3>
Significantly greater proportion of participants reached HbA1c&nbsp;&lt;7 % (&lt;53.0 mmol/mol) without weight gain at Week 26 or HbA1c&nbsp;&lt;7 % (&lt;53.0 mmol/mol) without weight gain at Week 26 and without hypoglycemia (&lt;70 mg/dL [&lt;3.9 mmol/L]) during the treatment period in the&nbsp;iGlarLixi&nbsp;versus&nbsp;BIAsp 30&nbsp;group (key secondary endpoints*; ITT population)
The proportion of participants reaching HbA1c&nbsp;&lt;7 % was greater with&nbsp;iGlarLixi&nbsp;versus&nbsp;BIAsp 30&nbsp;(exploratory analysis†; ITT population)

Percentage of participants reaching target
*&nbsp;hierarchical analysis adjusted for multiplicity;&nbsp;†not included in the multiple testing process
<h3>Key results: safety</h3>
<ul>
 <li>iGlarLixi&nbsp;demonstrated lower incidence and rates of ADA Level 1 and Level 2 hypoglycemia compared with&nbsp;BIAsp 30&nbsp;(safety population)</li>
 <li>iGlarLixi&nbsp;also demonstrated lower incidence and rates of ADA Level 2 hypoglycemia compared with&nbsp;BIAsp 30&nbsp;between bedtime and waking, or between midnight and 6am</li>
 <li>ADA Level 3 hypoglycemia (severe hypoglycemia; any event with severe cognitive impairment requiring assistance for recovery) was low with one event in the iGlarLixi group and two events in the&nbsp;BIAsp 30&nbsp;group</li>
</ul>
<h3>Incidence of anytime hypoglycemia, % (n)</h3>

<h4>Level 1 hypoglycemia</h4>
(ADA&nbsp;definition: &lt;70 mg/dL 
 [&lt;3.9 mmol/L] and ≥54 mg/dL 
 [≥3.0 mmol/L])

<h4>Level 2 hypoglycemia</h4>
(ADA&nbsp;definition: &lt;54 mg/dL 
 [&lt;3.0 mmol/L])

<h3>Relative odds reduction with iGlarLixi versus BIAsp 30</h3>
<ul>
 <li>-38%&nbsp; 
 <ul>
 <li>OR (95% CI):&nbsp;0.62 (0.47, 0.81)</li>
 </ul></li>
 <li>-45%
 <ul>
 <li>OR (95% CI):&nbsp;0.55 (0.42, 0.74)</li>
 </ul></li>
 <li>-55%
 <ul>
 <li>OR (95% CI):&nbsp;0.45 (0.28, 0.73)</li>
 </ul></li>
</ul>
<h3>Rates of anytime Hypoglycemia, PPY (Events)</h3>

<h4>Any hypoglycemic event</h4>

<h4>Level 1 hypoglycemia</h4>
(ADA definition: &lt;70 mg/dL 
 [&lt;3.9 mmol/L] and ≥54 mg/dL 
 [≥3.0 mmol/L])

<h4>Level 2 hypoglycemia</h4>
(ADA definition: &lt;54 mg/dL 
 [&lt;3.0 mmol/L])

<h3>Relative rate reduction with iGlarLixi versus BIAsp 30</h3>
<ul>
 <li>-33%
 <ul>
 <li>RR (95% CI):&nbsp;0.67 (0.49, 0.91)</li>
 </ul></li>
 <li>-29%
 <ul>
 <li>RR (95% CI):&nbsp;0.71 (0.52, 0.99)</li>
 </ul></li>
 <li>-60%
 <ul>
 <li>RR (95% CI):&nbsp;0.40 (0.23, 0.71)</li>
 </ul></li>
</ul>
The most commonly reported treatment-emergent AE in the&nbsp;iGlarLixi&nbsp;iGlarLixi group was nausea (7.7% vs 0% for&nbsp;BIAsp 30) while nasopharyngitis was the most commonly reported treatment-emergent AE in the&nbsp;BIAsp 30&nbsp;group (2.7% vs 3.2% for&nbsp;iGlarLixi) (safety population)
<table border="1" cellpadding="10" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td>n (%)</td>
 <td>iGlarLixi 
 (n=442)</td>
 <td>BIAsp 30 
 (n=441)</td>
 </tr>
 <tr>
 <td>Any treatment-emergent AE</td>
 <td>144&nbsp;(32.6)</td>
 <td>122&nbsp;(27.7)</td>
 </tr>
 <tr>
 <td>Any serious AE</td>
 <td>12&nbsp;(2.7)</td>
 <td>13&nbsp;(2.9)</td>
 </tr>
 <tr>
 <td>Any AE leading to 
 treatment discontinuation</td>
 <td>4&nbsp;(0.9)</td>
 <td>4&nbsp;(0.9)</td>
 </tr>
 <tr>
 <td>Any AE leading 
 to death</td>
 <td>0&nbsp;(0)</td>
 <td>2&nbsp;(0.5)</td>
 </tr>
 </tbody>
</table>
<h3>Conclusions</h3>
<ul>
 <li>Compared with twice-daily&nbsp;premix&nbsp;BIAsp 30&nbsp;once-daily FRC&nbsp;iGlarLixi&nbsp;demonstrated better glycemic control and weight benefit with less hypoglycemia</li>
 <li>iGlarLixi&nbsp;is a more efficacious, simpler, and well-tolerated alternative to&nbsp;premix BIAsp 30&nbsp;for advancing therapy in people with T2D previously suboptimally controlled with basal insulin plus OADs</li>
</ul>

Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes: Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial.

<h2>Suboptimal glycemic target achievement is common in people with T2D</h2>
<ul>
 <li>In a meta-analysis of 24 studies across 20 countries:&nbsp;the proportion of people achieving HbA1c targets was&nbsp;43%.1</li>
 <li>According to the IDMPS:&nbsp;&lt;50%&nbsp;of participants achieved a glycaemic goal of HbA1c &lt;7% in LMICs2</li>
</ul>

<h2>Real-world evidence shows poor glycemic control with premix</h2>
&lt;20%:&nbsp;UK THIN: &lt;20%&nbsp;achieved HbA1c &lt;7.5% 24 months after initiating with premix insulin3 ∼20%:&nbsp;IDMPS: ~20%&nbsp;on premix insulin reached HbA1c &lt;7% in LMICs4 &gt;28%:&nbsp;CoDiC: &gt;28%&nbsp;had their HbA1c &gt;8% for 17 months after switching from BI to premix insulin5

<h2>Many people with T2D eventually require injectable therapy.6-8</h2>
Globally, 30% of people with T2D use premix insulin9, but this is associated with:
<h3>Greater bodyweight gain vs BI:10</h3>
Premix insulin: +0.8 kg to +5.4 kg 
 BI: +0.1 kg to +3.5 kg
<h3>Increased hypoglycemia risk vs BI10</h3>
Premix insulin: 3.4 to 8.2 events PPY 
 BI: 0.7 to 5.4 events PPY
<ol>
</ol>

Unmet needs in adults with T2D receiving premixed insulin

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