<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>

Abbreviations

Reference

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.

TYPE-2-DIABETES

DIABETES

<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
Abbreviations
T2D, type 2 diabetes&nbsp;BI, basal insulin;&nbsp;IDMPS, International Diabetes Management Practices Study,&nbsp;LMIC, low-to-middle income country;&nbsp;THIN, The Health Improvement Network.BiAsp;&nbsp;CoDiC, Computerized Diabetes Care, Japan Diabetes Clinical Data Management Study Group;&nbsp;BI, basal insulin;&nbsp;PPY, per-patient-year
<ol>
</ol>

Unmet needs in adults with T2D receiving premixed insulin

Efficacy and safety of LixiLan, a Titratable fixed-ratio combination of Insulin glargine plus Lixisenatide in Type 2 Diabetes inadequately controlled on Basal insulin and Metformin: The LixiLan-L randomized trial.

<h2>Objective</h2>
Demonstrating the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with Type 2 diabetes inadequately controlled on Basal insulin with or without up to two oral glucose-lowering agents.¹

<h2>Study design</h2>
After a 6-week run-in# when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, HbA1c decreased from 8.5% to 8.1% then a total of 736 basal insulin-treated patients were randomized 1:1 for 30 weeks to:1

both titrated to fasting plasma glucose &lt;100 mg/dL (&lt;5.6 mmol/mol) up to a maximum dose of 60 units/day.
# Eligible patients entered a 6-week run-in phase during which any OAD other than metformin was stopped, patients were switched to iGlar (if they had previously been receiving another basal insulin), and the daily dose of iGlar was titrated and/or stabilized for all patients.

<h2>Endpoints¹</h2>
Primary efficacy endpoint:&nbsp;Change in HbA1c from baseline to week 30
Secondary efficacy endpoint:
<ul>
 <li>The percentage of patients reaching target HbA1c &lt;7.0% (53 mmol/mol) and ≤6.5% (48 mmol/mol) at week 30</li>
 <li>Change in 2-h PPG during the standardized liquid meal test.</li>
 <li>Change in bodyweight</li>
 <li>Change in average 7-point SMPG profile</li>
 <li>Percentage of patients reaching HbA1c &lt;7% (53 mmol/mol) with no body weight gain at week 30</li>
 <li>Percentage of patients reaching HbA1c &lt;7% (53 mmol/mol) with no body weight gain at week 30 and no documented symptomatic hypoglycemia during treatment</li>
 <li>iGlar daily dose</li>
 <li>FPG</li>
 <li>Percentage of patients reaching HbA1c &lt;7% (53 mmol/mol) at week 30 with no documented symptomatic hypoglycemia (PG ≤70 mg/dL [3.9 mmol/L]) during the 30-week randomized treatment period</li>
 <li>Percentage of patients requiring rescue therapy during the 30-week randomized treatment period.</li>
</ul>
Safety endpoint:&nbsp;Symptomatic hypoglycemia and gastrointestinal adverse events

<h2>Results</h2>
<h3>Primary efficacy endpoint</h3>

<ul>
 <li>Statistical superiority of iGlarLixi over iGlar was demonstrated for the change in HbA1c from baseline to week 30 (LS mean difference vs. iGlar –0.5%; 95% CI –0.6, –0.4; P&lt;0.0001)1</li>
 <li>Mean HbA1c levels were reduced more with iGlarLixi than with iGlar (-1.1% vs. – 0.6%, respectively), achieving final HbA1c levels of 6.9% (52 mmol/mol) for iGlarLixi and 7.5% (58 mmol/mol) for iGlar after 30 weeks of treatment.1</li>
</ul>

<h3>Secondary efficacy endpoint</h3>
<ul>
 <li>People achieving HbA1c target at week 30 Significantly greater proportion reached target with iGlarLixi vs. iGlar1</li>
</ul>

<ul>
 <li>Effect of iGlarLixi on FPG and PPG iGlarLixi combines the FPG effect of iGlar and the PPG effect of Lixi1,2</li>
</ul>

<ul>
 <li>Changes in body weight iGlarLixi was not associated with the weight gain often seen with insulin therapy¹</li>
</ul>

<h2>Safety endpoint</h2>
<ul>
 <li>Similar hypoglycemia with iGlarLixi vs. iGlar despite significantly better HbA1C with iGlarLixi1</li>
</ul>

<h2>Summary¹</h2>
<ul>
 <li>The primary objectives of the study were met as superiority of iGlarLixi in HbA1c change from baseline was shown versus iGlar.</li>
 <li>During the run-in, HbA1c was reduced from 8.5% to 8.1%</li>
 <li>Subsequent introduction of iGlarLixi (+ continuation of metformin where applicable): 
 <ul>
 <li>Further improved HbA1c from 8.1% to 6.9%</li>
 <li>Reduced 2 hour-PPG and glucose excursions was associated with weight reduction (-0.7 kg) with a significant difference of 1.4 kg versus iGlar (p&lt;0.0001)</li>
 </ul></li>
 <li>55% of people achieved HbA1c &lt;7% 
 <ul>
 <li>34% with HbA1c &lt;7% and no weight gain</li>
 <li>32% with HbA1c &lt;7% and no documented hypoglycemia</li>
 </ul></li>
 <li>The incidence of documented symptomatic hypoglycemia (≤70 mg/dL) was similar in the iGlarLixi and iGlar treatment groups</li>
 <li>Overall, iGlarLixi was well tolerated with a safety profile reflecting those of iGlar and lixisenatide</li>
</ul>

<h2>Post-Hoc analysis of Lixilan-L study³</h2>
At each baseline HbA1c level, more people reached HbA1c &lt;7.0% with iGlarLixi

This post hoc analysis of the LixiLan-L trial included both the screening phase and the treatment period for 30-week completers and evaluated the change in HbA1c from screening to Week 30, patients reaching HbA1c&lt;7% at Week 30, and iGlar and lixisenatide (Lixi) doses at Week 30 overall and according to HbA1c subcategoryat screening (HbA1c ≤ 8%, 8%&lt;HbA1c ≤9 %, and HbA1c&gt; 9%)

<h2>Indirect comparison: iGlarLixi in Lixilan-L and sequential iGlar + lixisenatide in GetGoal Duo-2⁴</h2>
iGlarLixi was associated with greater HbA1c reductions than sequential intensification with insulin glargine + lixisenatide

iGlarLixi showed numerically greater improvements in FPG and PPG compared with sequential intensification

*LS mean difference (standard error). Modified intent-to-treat population

<h2>Dosing⁵</h2>
1. iGlarLixi dosing in patients with previous basal insulin dose* ≥20, &lt;30 U

2. iGlarLixi dosing in patients with previous basal insulin dose ≥30, ≤60 U

*Therapy with basal insulin or GLP-1 RA or OAD other than metformin and SGLT2 inhibitors should be discontinued prior to initiation of Suliqua. Starting doses are based on previous insulin glargine 100 U/mL dose. For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% to choose the Suliqua starting dose. For any other basal insulin the same rule as for insulin glargine (100 units/ml) should be applied.
†Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide. The maximum daily dose is 60 units insulin glargine and 20 mcg lixisenatide corresponding to 60 dose steps. Consult prescribing information in your country as information and availability of the pens shown on the slide may vary.

References

The Lixilan-L Study

INTEGRATED-DIABETES-CARE

The first head-to-head RCT designed to compare the efficacy and safety of Gla-300 with IDeg-100 in participants with T2DM.
<h2>Background</h2>

However, direct clinical comparisons between these two-2nd generation basal insulin analogues are not available.
<h2>Study Design⁵</h2>
Multicentre, open-label, 1:1 randomised, active-controlled, 2-arm parallel-group, non-inferiority study in adult participants with uncontrolled T2DM

Gla-300 and IDeg-100 were self-administered once daily between 18:00–20:00 h5
Titrated weekly to target fasting SMPG of 4.4–5.6 mmol/L (80–100 mg/dL)
without hypoglycaemia5
Titration performed with aim of target achievement within 8–12 weeks post
randomisation (titration period)5
ᵃDoses titrated at least weekly
aWith the exception of a maximum of 8 consecutive days or 15 days total prior insulin use

<h2>Pre-Defined Endpoints⁵</h2>
<h3>Primary efficacy endpoint:</h3>
Change in HbA1c from baseline to week 24
<ul>
 <li>Analysed using a MMRM approach, adjusted for covariates including baseline HbA1c</li>
</ul>
<h3>Secondary efficacy endpoints:</h3>
<ul>
 <li>
 Change in HbA1c and fasting SMPG from baseline to week 12</li>
 <li>
 Change in FPG, fasting SMPG and 8-point SMPG profiles from baseline to week 24</li>
 <li>
 Variability of 8-point SMPG profiles</li>
</ul>
<h3>Safety endpoints:</h3>
<ul>
 <li>
 Incidence and annualised rates of confirmed hypoglycaemia (≤3.9 and &lt;3.0 mmol/L) over the full 24-week period, and during weeks 0–12 (titration period) and weeks 13–24 (maintenance period)</li>
 <li>
 TEAEs</li>
</ul>

<h2>Results</h2>
<h3>Primary efficacy endpoints:</h3>
Non-inferiority of Gla-300 vs IDeg-100 in HbA1c reduction at study end⁵

<h3>Secondary efficacy endpoints:</h3>
FPG and fasting SMPG reduction with Gla-300 vs IDeg-100 from baseline to study end⁵

Similar 8-point SMPG and variability profiles at baseline and study end⁵
Similar variability of 24-h SMPG and fasting SMPG at baseline and week 24 with both treatments.⁵

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(229, 231, 235);">
 Mean CV, %</td>
 <td style="background-color: rgb(229, 231, 235);">
 Gla-300</td>
 <td style="background-color: rgb(229, 231, 235);">
 IDeg-100</td>
 </tr>
 <tr>
 <td>
 24-h SMPG</td>
 <td>
 &nbsp;</td>
 <td>
 &nbsp;</td>
 </tr>
 <tr>
 <td>
 Baseline</td>
 <td>
 22.5</td>
 <td>
 23.4</td>
 </tr>
 <tr>
 <td>
 Week 24</td>
 <td>
 27.6</td>
 <td>
 28.0</td>
 </tr>
 <tr>
 <td>
 LS mean change</td>
 <td>
 3.7</td>
 <td>
 4.0</td>
 </tr>
 <tr>
 <td>
 Fasting SMPG</td>
 <td>
 &nbsp;</td>
 <td>
 &nbsp;</td>
 </tr>
 <tr>
 <td>
 Baseline</td>
 <td>
 13.8</td>
 <td>
 14.6</td>
 </tr>
 <tr>
 <td>
 Week 24</td>
 <td>
 16.5</td>
 <td>
 17.0</td>
 </tr>
 <tr>
 <td>
 LS mean change</td>
 <td>
 1.5</td>
 <td>
 2.0</td>
 </tr>
 </tbody>
</table>

<h3>Safety endpoints:</h3>
Incidence (%) and events per patient-year of confirmed (≤3.9 mmol/l) during titration period⁵

Treatment-emergent adverse events⁵
<ul>
 <li>
 No specific safety concerns were reported</li>
 <li>
 There was one death in the Gla-300 group (adenocarcinoma of the colon)</li>
 <li>
 Only one episode of severe hypoglycemia occurred during the entire study.</li>
</ul>
Confirmed hypoglycaemia included documented symptomatic or asymptomatic hypoglycaemia (≤70 mg/dL or &lt;54 mg/dL), and severe events if any; only 1 participant experienced severe hypoglycaemia (1 event), in the Gla-300 group, due to a skipped evening meal and not reducing her insulin dose after a non-severe event 2 days earlier. All p-values presented are nominal. Safety population (Gla-300, n=463; IDeg-100, n=462)⁵

<h3>Findings:</h3>
Hypoglycemia incidence by time of day⁷

Comparable glycaemic control and hypoglycaemia incidence over 24 weeks, regardless of SU/glinide use at screening⁶

ᵃp value to test heterogeneity of treatment-by-subgroup interaction. HbA1c reduction assessed in ITT population; hypoglycemia incidence assessed in safety population

<h2>Clinical Implications</h2>
<ul>
 <li>
 Gla-300 and IDeg-100 provide similar glycaemic control accompanied by comparable hypoglycaemia⁵&nbsp;</li>
 <li>
 Active and adequate titration can help patients achieve glycaemic goals – dose increases are associated with improved HbA1c levels⁸</li>
 <li>
 Early hypoglycaemic events during titration are associated with increased rates of treatment discontinuation, as well as long-term risk of hypoglycaemia⁹,¹⁰</li>
 <li>
 Gla-300 may offer an advantage in hypoglycaemia risk reduction vs IDeg-100 during the titration period in insulin-naïve patients with T2DM⁵</li>
</ul>

<h2>Conclusion</h2>
<ul>
 <li>Bright&nbsp;was the first direct comparison of Gla-300 vs IDeg-100: 
 <ul>
 <li>Similar glycaemic control for HbA1c and fasting SMPG</li>
 <li>Similar variability in 24-h SMPG and fasting SMPG</li>
 </ul></li>
 <li>
 During the full study and maintenance periods, anytime and nocturnal confirmed hypoglycaemia were comparable</li>
 <li>
 During the titration period (0–12 weeks), the rate of anytime and nocturnal confirmed hypoglycaemia were lower with Gla-300 vs IDeg-100</li>
</ul>

The Bright Study

Second-generation basal insulin analogs can be used as first choice in reducing real-world severe hypoglycemia (Baseline results of the iNPHORM study, USA)
This prospective investigation of real-world hypoglycemia risk stratification in the US suggested that clinicians should prioritize second-generation BIs over first-generation BIs, whenever feasible.

<h2>Main Takeaway</h2>
<ul>
 <li>Finding from the iNPHORM&nbsp;study corroborate that second-generation BI analogs versus first-generation&nbsp;BIs reduce the rate of SH, irrespective of bolus insulin therapy.</li>
 <li>Daytime SH and nocturnal SH were comparable in respondents&nbsp;receiving first-generation versus second-generation BIs.</li>
 <li>Whenever possible, clinicians should prioritize second-generation BIs over first-generation BIs.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>Previous trials reported that second-generation BIs reduce SH compared to first-generation BIs.</li>
 <li>However, owing to the tightly controlled nature of clinical trials, their applicability in real world can be limited.</li>
 <li>The population-based iNPHORM study assessed the effect of second-generation versus first-generation BIs on SH frequency in the real-world practice to complement RCT findings.</li>
</ul>

<h2>Key Results</h2>
<ul>
 <li>The iNPHORM study cohort comprised US participants (≥18 to ≤90 years) with T1DM and T2DM taking insulin and/or secretagogues for ≥1 year. 
 <ul>
 <li>Participants were included from a probability-based internet panel: Approximately 68,000 people with diabetes 
 <ul>
 <li>T1DM: n = 10,000; T2DM: n = 58,000</li>
 <li>26,387 panelists initiated screening</li>
 </ul></li>
 </ul></li>
 <li>
 Participants who were unable to understand English, currently pregnant or pregnant in the previous year, and currently enrolled in a drug trial were excluded from study.</li>
 <li>
 Overall, 2,339 participants were eligible for the study; of these, 1,694 completed the baseline questionnaire, of whom 569 reported BI use and were included in the sub-analysis (age: 52.33 [SD, 13.82] years; female: 54.5%; T1DM: 21.6%).</li>
 <li>
 Key outcomes: Crude, real-world frequency of SH* among individual taking first-generation or second-generation BIs and quantification of the potential casual effects of second- versus first-generation BIs on SH frequency</li>
 <li>
 Multivariable negative binomial regression was used to isolate the effect of second-generation versus first-generation BIs (+/- bolus insulin) on self-reportedrates of past-year total SH, daytime SH, and nocturnal SH. Confounding variables were identified from a directed acyclic graph.</li>
 <li>
 Approximately 10.0% versus 54.1% and 7.6% versus 28.3% participants reported receiving second-generation versus first-generation BIs with and without bolus insulin, respectively.</li>
 <li>Adjusted SH incidence rate ratios in respondents receiving first-generation versus second-generation BIs were as follows: 
 <ul>
 <li>Total SH: Respondents without bolus insulin = IRR: 2.70, 95% CI: 1.07–6.84; respondents with bolus insulin = IRR: 1.17, 95% CI: 0.552–2.46</li>
 </ul></li>
 <li>Comparable effects were found for daytime and nocturnal SH in respondents receiving first-generation versus second-generation BIs: 
 <ul>
 <li>Daytime SH: Respondents without bolus insulin = IRR: 2.26, 95% CI: 0.817–6.24; respondents with bolus insulin = IRR: 1.43, 95% CI: 0.625–3.29</li>
 <li>Nocturnal SH: Respondents without bolus insulin = IRR: 3.55, 95% CI: 0.39–15.03; respondents with bolus insulin = IRR: 1.07, 95% CI: 0.38–3.03</li>
 </ul></li>
</ul>

Reducing risk of severe hypoglycemia - iNPHORM Study

Venous thromboembolism incidence among patients recommended for pharmacologic thromboembolism prophylaxis after cesarean delivery in selected guidelines
Adapted from Federspiel JJ, et al. J Thromb Haemost. 2021;19:830–838.

<h2>Key Takeaway</h2>
Incidence of VTE for high-risk caesarean delivery is unclear in the guidelines and risk stratification approaches are widely promulgated. This retrospective cohort study highlights widely different proportions of risk of VTE following delivery across different guidelines in US
Based on the chosen guideline:
<ul>
 <li>Incidence of pharmacologic recommendation varied from 0.2% (2018 ASH) to 73.4% (2015 RCOG)</li>
 <li>Incidence of VTE varied from 2.5 (2015 RCOG) to 35.2 (2018 ASH) per 1000 deliveries</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>VTE, particularly PE is a leading cause of pregnancyrelated morbidity and mortality in US and the incidence is increasing</li>
 <li>In the US, it is unknown what drives the implementation of the guidelines identifying the need of pharmacologic prophylaxis after cesarean delivery</li>
 <li>The relationship between the various patient selection criteria for pharmacologic prophylaxis and the subsequent incidence of VTE is unclear</li>
</ul>

<h2>Study Design</h2>
To estimate the percentage of cesarean delivery patients for which pharmacologic VTE would be recommended and subsequent incidence of VTE based on selected guidelines: ACOG, RCOG, ACCP, or ASH
Retrospective cohort study 
 (N = 1,235,149 from 4620 hospitals)
Women who underwent cesarean delivery and were recommended for pharmacologic prophylaxis according to guidelines were included
Outcomes:
<ul>
 <li>Incidence of VTE among patients recommended for pharmacologic prophylaxis</li>
 <li>Length of stay, inpatient charges, and discharge disposition</li>
</ul>
October 2015 – December 2017
Nationwide Readmissions Database, Healthcare Cost and Utilization project, Agency for Healthcare Research and Quality
<ul>
 <li>Diagnosis and procedure codes* were used to identify patients undergoing cesarean delivery, the incidence of VTE, and risk factors used to stratify risk in the existing guidelines</li>
 <li>Time–to–event analysis was used to analyze data, stratified by risk categorization in ACOG 2011, ACCP 2012, RCOG 2015, and ASH 2018 guidelines</li>
</ul>

<h2>Key Highlights</h2>
<ul>
 <li>Patients (N = 1,235,149) had a mean age of 29.8 years and the mean length of stay for the hospitalizations was 3.5 days</li>
 <li>Patients requiring pharmacologic prophylaxis</li>
</ul>
<ul>
 <li>ACOG 2011–0.3%</li>
 <li>ASH 2018-0.2%</li>
 <li>ACCP 2012–16.2%</li>
 <li>RCOG 2015–73.4%</li>
</ul>

The criteria which yielded biggest difference in VTE risk between low and high-risk patients
<ul>
 <li>ACOG 2011&nbsp;(RR:&nbsp;15.7; 95% CI, 11.7–19.9)</li>
 <li>ASH 2018 (RR:&nbsp;17.3; 95% CI, 12.3–22.2)</li>
 <li>ACCP 2012&nbsp;(RR:&nbsp;3.9; 95% CI, 3.4–4.3)</li>
 <li>RCOG 2015&nbsp;(RR:&nbsp;2.2; 95% CI, 1.9–2.5)</li>
</ul>
Large sample size and data designed to be representative of the US population is the strength of this stud

<h2>Limitations</h2>
<ul>
 <li>Retrospective study design</li>
 <li>Use of administrative (billing) data, which may lead to inaccuracies, missing information, code complications or measurement errors</li>
 <li>Any VTE identified and managed solely on an outpatient basis would be excluded</li>
</ul>
*Performance of cesarean delivery was identified using ICD–10–CM procedure codes 10D00Z0, 10D00Z1, and 10D00Z2

VTE Incidence after Cesarean Delivery in Selected Guidelines

THROMBOSIS

CARDIOLOGY

Recurrence of venous thromboembolism in patients with recent gestational deep vein thrombosis or pulmonary embolism: Findings from the RIETE Registry
Adapted from Barillari G, et al. European Journal of Internal Medicine. 2016; 32:53-9.

<h2>Key Takeaway</h2>
<ul>
 <li>This study provides new insights on VTE recurrence rate in DVT or PE patients during pregnancy and postpartum period</li>
 <li>PE is the most frequent type of VTE occurring in pregnant women with history or recent or previous surgery</li>
 <li>Assessment of thrombotic risk is important for better decision making regarding antithrombotic management</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>1 in 1000 pregnant women are estimated to have complications due to VTE, which is the leading cause of maternal mortality and morbidity worldwide1-3</li>
 <li>VTE during pregnancy or post-partum is an instigated event such as VTE secondary to&nbsp;surgery, prolonged immobilization, oral contraception, trauma, or hormonal replacement therapy4-8</li>
 <li>There is discrepancy in VTE management in pregnancy among different centers and countries as no clear clinical trials has studied this population</li>
</ul>

<h2>Objective</h2>
<ul>
 <li>To investigate rate of DVT or PE recurrence, major bleeding, or death in women during pregnancy or puerperium</li>
 <li>To identify predictors for VTE recurrence</li>
</ul>

<h2>Study Design</h2>
Inclusion criteria:&nbsp;Women confirmed with symptomatic, acute DVT or PE developed during pregnancy or puerperium (up to 42 days after delivery) enrolled in the international, multicenter, prospective RIETE registry
Study period:&nbsp;January 2001 and June 2013
Exclusion criteria:&nbsp;Patient involvement in therapeutic trials with a blind medication or a follow-up of less than three months after the diagnosis
Primary outcome:&nbsp;Recurrent PE (with or without DVT signs), recurrent DVT or major bleeding
Secondary outcome:&nbsp;Fatal VTE and fatal bleeding

<h2>Key Results</h2>
Of the total 46,770 RIETE registry patients, 607 women were objectively confirmed with VTE during pregnancy or puerperium

<ul>
 <li>Women with recent surgery showed the incidence of PE more than DVT</li>
 <li>During pregnancy DVT was more common than PE, PE was more common during puerperium</li>
 <li>The most common drug used as initial therapy was LMWH, and then UFH</li>
</ul>

<ul>
 <li>The cumulative incidence of VTE recurrence was low at 2 years 3.3% (95% CI, 1.5–5.0)</li>
 <li>Recurrent incidence rate was 2.28 events/100 patients-year</li>
 <li>No significant differences were observed between DVT and PE for initial VTE presentation</li>
 <li>Use of thrombolytics and inferior vena cava filter in initial treatment was associated with increased risk of VTE recurrence</li>
</ul>

<h2>Limitations</h2>
RIETE is an observational registry, therefore, results must be interpreted with caution while suggesting changes or adapting any treatment strategies

Recurrence of VTE in Patients with Recent Gestational DVT or PE

PTS is a frequent DVT complication in women that severely impacts QoL and is under-recognized despite high disease burden.

<h2>Key Takeaway</h2>
In this session, Prof. Susan R. Kahn discusses PTS in women and suggests that:
<ul>
 <li>It is a common, occasionally severe DVT complication, even in young women</li>
 <li>Main risk factors include extensive and recurrent ipsilateral DVT, persisting leg symptoms 1 month post DVT, obesity, older age, smoking, post-natal DVT</li>
 <li>ECS is the current standard of care for treatment of PTS</li>
 <li>Ongoing research seeks to identify medication and interventional approaches</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>PTS develops in 33–50% of patients with DVT after anticoagulation therapy and adversely affects QoL, decreases productivity, and is severe in 5–10%.</li>
</ul>

<h2>Key results</h2>
Common clinical features of PTS&nbsp;(<a href="https://www.sciencedirect.com/science/article/pii/S000649712032228X?via%3Dihub" target="_blank">Rabinovich A and Kahn SR, 2018</a>)
<ul>
 <li>Leg symptoms: Most common ones are heaviness, pain, and swelling, while others include itching, cramping, paresthesia, and bursting pain</li>
 <li>Signs: Edema, hyperpigmentation, peri-malleolar telangiectasia, venous ectasia, redness, dependent cyanosis, lipodermatosclerosis, leg ulceration</li>
 <li>Features may be intermittent or persistent, and may vary across patients 
 <ul>
 <li>Worsens while standing and walking; improves with leg elevation, and rest</li>
 <li>Ranges from mild to severe symptoms, limiting work and functioning</li>
 </ul></li>
 <li>Severe PTS and venous ulcer can develop in 5–10% of women and are chronic, painful, slow to heal, often recurring, and requires medical scrutiny.</li>
</ul>
How often does PTS occur in women?&nbsp;(<a href="https://onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2141.2000.01877.x?sid=nlm%3Apubmed" target="_blank">McColl MD, et al. 2000</a>)
<ul>
 <li>Retrospective cohort study of 43 young women (≤50 years) with prior VTE episodes (63% pregnancy-related); examined ~4 years after VTE</li>
</ul>
<figure class="table" style="width:100%;">
 <table>
 <tbody>
 <tr>
 <td style="background-color:rgb(229, 231, 235);">Prior VTE</td>
 <td style="background-color:rgb(229, 231, 235);">N</td>
 <td style="background-color:rgb(229, 231, 235);">All PTS</td>
 <td style="background-color:rgb(229, 231, 235);">Mild PTS</td>
 <td style="background-color:rgb(229, 231, 235);">Moderate PTS</td>
 </tr>
 <tr>
 <td>Single DVT</td>
 <td>43</td>
 <td>74%</td>
 <td>67%</td>
 <td>7%</td>
 </tr>
 <tr>
 <td>Recurrent DVT</td>
 <td>9%</td>
 <td>100%</td>
 <td>55%</td>
 <td>44</td>
 </tr>
 </tbody>
 </table>
</figure>
Risk of PTS is quite high following pregnancy-related DVT due to:
<ul>
 <li>More involvement of femoral and iliac veins than in non-pregnant DVT</li>
 <li>More anatomically extensive proximal DVT being a risk factor itself</li>
</ul>
<figure class="table" style="width:100%;">
 <table>
 <tbody>
 <tr>
 <td style="background-color:rgb(229, 231, 235);">Study</td>
 <td style="background-color:rgb(229, 231, 235);">N</td>
 <td style="background-color:rgb(229, 231, 235);">Proximal DVT (%)</td>
 <td style="background-color:rgb(229, 231, 235);">Left DVT (%)</td>
 <td style="background-color:rgb(229, 231, 235);">Antenatal DVT (%)</td>
 <td style="background-color:rgb(229, 231, 235);">Duration of assessment</td>
 <td style="background-color:rgb(229, 231, 235);">PTS (%)</td>
 <td style="background-color:rgb(229, 231, 235);">Severity (%)</td>
 </tr>
 <tr>
 <td><a href="https://www.sciencedirect.com/science/article/abs/pii/S0049384815302292?via%3Dihub" target="_blank">Wik HS, et al 2016</a></td>
 <td>182</td>
 <td>82</td>
 <td>75</td>
 <td>60</td>
 <td>9.6 post pregnancy</td>
 <td>41</td>
 <td>19 (moderate or severe)</td>
 </tr>
 <tr>
 <td><a href="https://onlinelibrary.wiley.com/doi/10.1111/j.1538-7836.2012.04690.x" target="_blank">Wik HS, et al 2012</a></td>
 <td>313</td>
 <td>83</td>
 <td>75</td>
 <td>49</td>
 <td>9.1 after first VTE</td>
 <td>42</td>
 <td>7 (severe)</td>
 </tr>
 </tbody>
 </table>
</figure>
Independent predictors of PTS after pregnancy related DVT*&nbsp;(<a href="https://www.sciencedirect.com/science/article/abs/pii/S0049384815302292?via%3Dihub" target="_blank">Wik HS, et al. 2016</a>)
<ul>
 <li>Age &gt;33 vs ≤33 (Ref) years: aOR = 3.9 (95% CI: 1.8–8.3),&nbsp;P&nbsp;&lt;0.001</li>
 <li>Daily vs non-daily (Ref) smokers: aOR = 2.9 (95% CI: 1.3–6.4),&nbsp;P&nbsp;= 0.011</li>
 <li>Post- vs ante-natal (Ref) pregnancy: aOR = 3.5 (95% CI: 1.8–7.0),&nbsp;P&nbsp;&lt;0.001</li>
 <li>Proximal vs distal (Ref) DVT location: aOR = 2.6 (95% CI: 1.1–6.4),&nbsp;P&nbsp;= 0.037</li>
 <li>HsCRP (&gt;0.84 g/L): aOR = 2.4 (95% CI: 1.2–4.8),&nbsp;P&nbsp;= 0.01</li>
</ul>
PTS effect on QoL post DVT in 1,040 women (18–64 years)&nbsp;(<a href="https://journals.sagepub.com/doi/10.1177/0268355517698620?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub%20%200pubmed" target="_blank">Ljungqvist M, et al. 2018</a>)
<ul>
 <li>At 6 years median follow-up: Women with PTS had severely impaired QoL across all measures (P &lt;0.001)</li>
 <li>Other predictors: older age, obesity, physical inactivity, and recurrent VTE</li>
</ul>
ECS—Standard of care for PTS, but compliance is crucial
<ul>
 <li>Reduces edema, leg pain, and heaviness</li>
 <li>Instructed to apply in the morning and remove at bedtime or early evening</li>
 <li>Knee-length ECS: More comfortable and easier to apply than thigh-length ECS, with comparable physiologic effects</li>
 <li>Begin with knee length 30–40 mm Hg ECS: If difficult to apply or restrictive, try 20–30 mm Hg ECS; some patients may need higher compression strengths (e.g., 40–50 mm Hg) to control edema</li>
</ul>
Other types of compression therapy for moderate-to-severe PTS
<ul>
 <li>Intermittent pneumatic compression devices for severe PTS: Effective, but impractical (patients need to remain stationary ≥2 h/day), costly (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1230312/" target="_blank">Ginsberg JS, et al. 1999</a>)</li>
 <li>Portable, battery-powered lower-limb venous return aid device for moderate or severe PTS: Better QoL and lower PTS severity while using the device alone or in conjugation with ECS (<a href="https://www.thieme-connect.com/products/ejournals/abstract/10.1160/TH07-09-0546" target="_blank">O’Donnell MJ, et al. 2008</a>)</li>
</ul>
Medications for PTS treatment&nbsp;(<a href="https://www.ahajournals.org/doi/10.1161/CIR.0000000000000130?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub%20%200pubmed" target="_blank">Kahn SR, et al. 2016; Kahn SR, et al. 2014; Cohen JM, et al. 2012</a>)
<ul>
 <li>Low quality evidence for efficacy of rutosides, horse chestnut extract, hidrosmin, and defibrotide (short-term use i.e., 3–12 weeks)</li>
 <li>Rigorous multi-center studies needed to assess efficacy, sustainability, safety</li>
 <li>Ongoing Canadian RCT: MUFFIN PTS Trial (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438950/" target="_blank">Galanaud JP, et al. 2021</a>)</li>
 <li>MPFF b.i.d. vs placebo b.i.d. (6 months) (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438950/" target="_blank">Li KX, et al. 2021</a>)</li>
</ul>
Exercise training for PTS treatment&nbsp;(<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3017252/" target="_blank">Kahn SK, et al. 2011</a>)
<ul>
 <li>A 6-month RCT (26-week) comprising strengthening, stretching, and aerobic components to improve leg strength and flexibility and overall CV fitness</li>
 <li>Exercise group demonstrated improved QoL, leg strength and flexibility, as well as a trend towards an improved Villalta PTS score.</li>
</ul>
Surgery or interventional approaches to treat moderate or severe PTS
<ul>
 <li>Case reports and case series suggest that venous bypass grafting, valve reconstruction, vein dilation and stent implantation, PCDT, endophlebectomy, and interruption of perforating veins are useful for moderate or severe PTS.</li>
 <li>No methodologically rigorous, comparative trials have been conducted to test the efficacy and safety of treatments for moderate or severe PTS.</li>
 <li>Ongoing&nbsp;<a href="https://bloodclotstudy.wustl.edu/c-tract/" target="_blank">C-Tract Trial</a>&nbsp;seeks to address this gap.</li>
</ul>
*OR adjusted for: 1) Postnatal, proximal DVT, age &gt;33 years at the time of index pregnancy and smoking before the index pregnancy

Post Thrombotic Syndrome in Women

Maternal and perinatal outcomes of venous thromboembolism in high-risk cohort using a multidisciplinary treatment approach
Adapted from Ernst DM et al. Int J Gynecol Obstet. 2021;154(3): 500–507.

<h2>Key Takeaway</h2>
<ul>
 <li>Perinatal surveillance of pregnant women with a high-risk of VTE should include guided thromboprophylaxis and close observation to decrease perinatal risk</li>
 <li>Multidisciplinary assessment of VTE in high-risk pregnant women should be supported</li>
 <li>Women at high risk of thrombosis during pregnancy are at high risk of pre-eclampsia, preterm delivery, and growth restriction</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>Pregnant women are at &gt;4 times higher risk of VTE compared with nonpregnant women1</li>
 <li>Thromboprophylaxis in these patients is guided by a low level of evidence due to limited data from RCT2,3</li>
 <li>Risk of VTE is five-fold higher during puerperium</li>
 <li>An alternative approach in these patients is development of protocols for risk stratification and pharmacological thromboprophylaxis</li>
</ul>

<h2>Study Design</h2>
A cohort of pregnant women prospectively referred to the multidisciplinary clinic of the Maternal-Fetal Group of the Red de Salud UC-Christus for a high risk of VTE between January 1, 2007 to December 31, 2019 were analyzed
Inclusion criteria 
 All pregnant women
Exclusion criteria 
 Women seeking preconception advice regarding the risk of VTE who did not become pregnant during the period of the analysis
A&nbsp;modified diagnostic workup algorithm&nbsp;and a&nbsp;therapeutic algorithm&nbsp;were developed based on consensus guidelines

<h2>Key Results</h2>
Patient population
<ul>
 <li>Total of 148 pregnancies included</li>
 <li>Median age: 32 years, 26% patients &gt;35 years</li>
</ul>
Clinical characteristics
<ul>
 <li>High risk VTE: 57% (n=85)</li>
</ul>

Diagnostic workup
<ul>
 <li>Thrombophilia: 57% (n=85)</li>
 <li>Most common thrombophilia was APS (34%; n=29), more frequent in women with obstetric conditions than with prior VTE episodes</li>
</ul>

ASA and LMWH therapy
<ul>
 <li>VTE under prophylactic or therapeutic treatment was 0% during pregnancy and 3% during puerperium</li>
</ul>
Perinatal outcomes

Obstetric complications among live births (%)

<h2>Limitations</h2>
<ul>
 <li>Study design does not indicate if the chosen treatment management option was better than other alternatives</li>
 <li>Lack of control group (due to ethical reasons)</li>
 <li>Additional efforts are warranted to decrease perinatal risk</li>
</ul>
Abbreviations
ASA, acetylsalicylic acid; APS, antiphospholipid syndrome;&nbsp;LMWH, low molecular weight heparin;&nbsp;VTE, venous thromboembolism.

Maternal and Perinatal Outcomes of VTE

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