INTEGRATED-DIABETES-CARE

DIABETES

Diabetes your type: Testimonial by Dr. Hussein​

Dr. Hussein provides information about Diabetes and how it can be&nbsp;controlled with the support of the healthcare team and the family.

Diabetes Your Type: Testimonial by Dr. Bassam​

Dr. Bassem provides comprehensive explanation on Type 1 Diabetes&nbsp;and how insulin as well as sugar level can be controlled/measured for these&nbsp;patients.

Expert consensus statement on management of older adults with type 2 diabetes (T2D)

ADA/EASD guidelines suggest that in older adults with diabetes, glycaemic targets and therapeutic choices should be modified by routinely assessing frailty. Know more about the details of such recommendation and treatment simplification, switching, or de-escalation in older population through this video.

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.

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