<h2>Objective</h2>
To compare the effectiveness of&nbsp;iGlarLixi&nbsp;with&nbsp;BI+RAI&nbsp;in people with T2D advancing from BI therapy using real-world evidence

References

<h2>Study Design</h2>
To compare the effectiveness of&nbsp;iGlarLixi&nbsp;with&nbsp;BI+RAI&nbsp;in people with T2D advancing from BI therapy using real-world evidence 
 Retrospective, observational, cohort study of anonymized patient data collected from the OMOP US Ambulatory EMRs database 
 POPULATION
<ul>
 <li>≥18 years old with T2D</li>
 <li>At least one prescription of BI within the baseline period</li>
 <li>Valid HbA1c and body weight values during baseline and post-index period</li>
</ul>
Participants matched to&nbsp;iGlarLixi&nbsp;and&nbsp;BI+RAI&nbsp;groups 1:1 using propensity score matching

Abbreviations

<h2>Study endpoints</h2>
<h3>Primary Endpoints</h3>
Non-inferiority of&nbsp;iGlarLixi&nbsp;vs&nbsp;BI+RAI&nbsp;in HbA1c&nbsp;change from baseline to 6 months (non-inferiority margin 0.3 %)*
<h3>Secondary Endpoints</h3>
Superiority of&nbsp;iGlarLixi&nbsp;vs&nbsp;BI+RAI&nbsp;in:†
<ol>
 <li>Change in body weight from baseline to 6 months</li>
 <li>Composite target achievement of HbA1c &lt;7 % (&lt;53 mmol/mol) without any hypoglycemia‡ and without any body weight gain at 6 months</li>
 <li>Change in HbA1c&nbsp;from baseline to 6 months</li>
</ol>

<h3>Additional Endpoints</h3>
<ul>
 <li>Hypoglycemia incidence and event rate at 6-month follow-up</li>
 <li>Subgroup analysis in participants with baseline age ≥65 years and HbA1c ≥9 % (≥75 mmol/mol)</li>
</ul>
*The primary endpoint of between-treatment difference in mean HbA1c change was assessed using a paired t-test (one-sided, α=0.025), with a non-inferiority margin of 0.3 % (3 mmol/mol); †Key secondary endpoints were assessed in hierarchical order (to control overall type I error) to demonstrate superiority of iGlarLixi vs BI+RAI in 1) body weight change; 2) composite target achievement; and 3) HbA1c change (two-sided, α=0.05). Paired t-tests were used to compare between-treatment differences in body weight while the odds ratio of participants reaching the composite target endpoint between treatment cohorts was estimated by logistic regression: ‡Defined as ICD-10-CM code E16.2 and SNOMED code 4154498, or blood glucose &lt;70 mg/dL [&lt;3.9 mmol/L]) confirmed either by laboratory testing or observation results 
 BI, basal insulin; ICD-10-CM, International Classification of Diseases-10 Clinical Modification; iGlarLixi, insulin glargine 100 U/mL and lixisenatide; RAI, rapid-acting insulin; SNOMED, Systemized Nomenclature of Medicine

<h2>Baseline characteristics after propensity score matching (PSM)</h2>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <thead>
 <tr>
 <th scope="col">&nbsp;</th>
 <th scope="col">iGlarLixi (N=814)</th>
 <th scope="col">BI+RAI (N=814)</th>
 <th scope="col">STD DIFF</th>
 </tr>
 </thead>
 <tbody>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Age at index, years, mean ±&nbsp;SD</td>
 <td style="text-align: center;">61.5&nbsp;± 11.0</td>
 <td style="background-color: rgb(244, 242, 246); text-align: center;">61.6&nbsp;± 11.1</td>
 <td style="text-align: center;">0.01</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Sex, female, n(%)</td>
 <td style="text-align: center;">392 (48.2)</td>
 <td style="background-color: rgb(244, 242, 246); text-align: center;">400 (49.1)</td>
 <td style="text-align: center;">0.02</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">Body weight, kg, mean&nbsp;± SD</td>
 <td style="text-align: center;">100.1&nbsp;± 22.7</td>
 <td style="background-color: rgb(244, 242, 246); text-align: center;">99.0&nbsp;± 23.5</td>
 <td style="text-align: center;">0.04</td>
 </tr>
 <tr>
 <td style="background-color: rgb(244, 242, 246);">HbA1c,&nbsp;mean&nbsp;± SD*, % (mmol/mol)</td>
 <td style="text-align: center;">9.2&nbsp;± 1.8&nbsp; 
 (77&nbsp;± 20)</td>
 <td style="background-color: rgb(244, 242, 246); text-align: center;">9.2&nbsp;± 1.7 
 (77&nbsp;± 19)</td>
 <td style="text-align: center;">0.01</td>
 </tr>
 </tbody>
</table>

PSM generated cohorts with balanced baseline characteristics Participants had high baseline HbA1c and a large proportion had comorbidities
*Closest to index date; †Balance between PSM groups assessed using STDDIFF and a threshold of 0.1

Primary outcome
<ul>
 <li>Both&nbsp;iGlarLixi&nbsp;and&nbsp;BI+RAI&nbsp;improved overall glycemic control</li>
 <li>iGlarLixi&nbsp;was non-inferior to&nbsp;BI+RAI&nbsp;in change in HbA1c from baseline to month 6</li>
</ul>

*one-sided p-value assessing non-inferiority of iGlarLixi vs BI+RAI with non-inferiority margin = 0.3 % (3 mmol/mol); †GlarLixi mmol/mol values were 77 ± 20 at baseline and 69 ± 19 at follow-up; ‡BI+RAI mmol/mol values were 77 ± 19 at baseline and 68 ± 19 at follow-up

<h2>Secondary outcomes</h2>
<h3 style="text-align: center;">Mean body weight change</h3>

Superiority of&nbsp;iGlarLixi&nbsp;vs&nbsp;BI+RAI&nbsp;in body weight change from baseline to 6 months was achieved
<h3 style="text-align: center;">HbA1c&nbsp;&lt;7 % without hypoglycemia and weight gain*</h3>

As superiority of&nbsp;iGlarLixi&nbsp;vs&nbsp;BI+RAI&nbsp;for composite endpoint achievement was not reached, superiority in HbA1c&nbsp;change was not tested
*proportion of participants achieving HbA1c &lt;7 % (&lt;53 mmol/mol) without any hypoglycemia and without body weight gain at 6-month follow-up; †two-sided p-value assessing superiority of iGlarLixi vs BI+RAI

<h2>Other Outcomes</h2>
At 6-month follow-up, there were very few hypoglycemia events recorded for either treatment group, likely due to underreporting, and no significant between-treatment differences were seen in incidence or rates Sensitivity analyses&nbsp;showed similar results*

Participants ≥65 years
<ul>
 <li>Mean HbA1c&nbsp;from baseline to 6-month were similar for&nbsp;iGlarLixi&nbsp;and&nbsp;BI+RAI, and comparable in magnitude to overall population</li>
 <li>HbA1c&nbsp;&lt;7 % (&lt;53 mmol/mol) without hypoglycemia or body weight gain was achieved by 11.6% and 7.7% participants treated with&nbsp;iGlarLixi&nbsp;and&nbsp;BI+RAI, respectively</li>
</ul>

Participants with baseline HbA1c ≥9 % (≥75 mmol/mol)
<ul>
 <li>iGlarLixi&nbsp;and&nbsp;BI+RAI&nbsp;were associated with similar HbA1c reductions from baseline to 6-months</li>
 <li>HbA1c&nbsp;target &lt;7 % (&lt;53 mmol/mol) without hypoglycemia or body weight gain was achieved by ~5.0% of participants with both&nbsp;iGlarLixi&nbsp;and&nbsp;BI+RAI</li>
</ul>

Subgroup analysis results reflected outcomes of the overall population
*Sensitivity analyses included: analysis of primary and key secondary endpoints in participants identified between 01 January 2017 and 30 June 2019 to assess possible impacts of COVID-19 pandemic; analysis of key primary and secondary endpoints in participants who had ≥1 additional treatment prescription within 180 days post-index date, and participants who had ≥1 treatment prescription within 120 days post-index date; the proportion of participants achieving the composite target of HbA1c &lt;8 % without any hypoglycemia and without any body weight gain

Strengths
<ul>
 <li>First study comparing&nbsp;iGlarLixi&nbsp;with a&nbsp;BI+RAI&nbsp;regimen for T2D treatment in a real-world setting</li>
 <li>Robust sensitivity analyses confirmed the main findings</li>
 <li>PSM helps reduce bias from potential confounders</li>
</ul>

Limitations
<ul>
 <li>Not a randomized controlled trial (RCT). Lack of randomization may lead to bias from unknown confounders</li>
 <li>Risk of selection bias, e.g. HCP choices of prescribing different regimens</li>
 <li>Levels of treatment adherence will likely be lower than those achieved in an RCT which could minimize between-treatment differences</li>
 <li>Risk of potential missing information in the IQVIA database, e.g. few hypoglycemia events reported</li>
</ul>

<h2>Conclusion</h2>
<ul>
 <li>iGlarLixi&nbsp;was non-inferior to&nbsp;BI+RAI&nbsp;in HbA1c reductions achieved after 6 months therapy</li>
 <li>iGlarLixi&nbsp;did not result in weight gain while weight gain was seen with&nbsp;BI+RAI</li>
 <li>Hypoglycemia was low in both&nbsp;iGlarLixi&nbsp;and&nbsp;BI+RAI&nbsp;groups, likely due to under-reporting, with no between-treatment differences observed</li>
 <li>The present RWE results support evidence from the DUAL VII RCT comparing an FRC with a&nbsp;BI+RAI&nbsp;regimen1</li>
 <li>RWE shows&nbsp;iGlarLixi&nbsp;provides similar glycemic outcomes to&nbsp;BI+RAI&nbsp;after 6 months, with the added benefit of less weight gain and a simpler regimen</li>
</ul>

IGlarLixi vs basal plus rapid-acting insulin in adults with type 2 diabetes advancing from basal insulin therapy: The SoliSimplify real-world study

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