A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus

Phase 4

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: iGlarLixi (insulin glargine/lixisenatide)

• Registration Number: NCT06716424
• Lead Sponsor: Sanofi

Brief Summary

This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.

Detailed Description

The study duration will be up to 27 weeks, with a treatment duration approximately 24 weeks.

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Study Start: 2025-01-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-07-21
• Study Completion: 2025-07-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Participants must be ≥18 years of age, at the time of signing the informed consent
• Participants with Type 2 Diabetes diagnosed for at least 1 year at the time of screening on treatment with Metformin +/- OADs or basal insulin/GLP-1RA for a minimum period of 6 months prior to screening
• HbA1c between ≥ 7.5% and ≤10.5% inclusive, during screening
• Participant with BMI >= 25 kg/m2 (as per Endocrine Society of India, Ref 12)
• Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27)
• Signed informed consent

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• Type 1 Diabetes mellitus or any diabetes other than T2DM
• Prior use of any combination of Basal Insulin + GLP-1 RA Fixed Ratio or Free Combination, Premix Insulin, Basal bolus therapy
• Basal insulin dose >50 U at screening
• Any clinically-significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment
• Known presence of factors that interfere with the HbA1c measurement (e.g., specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival)
• History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit
• Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
• Use of weight loss drugs (including over-the-counter and herbal medications) within 12 Weeks prior to the screening visit
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit
• Likelihood to require treatment prohibited by the protocol during the study.
• Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening visit or concomitant enrollment in any other clinical study involving an investigational study treatment
• Any specific situation during study implementation/course that may raise ethics considerations
• History of hypoglycemia unawareness
• Patients with known hypersensitivity to lixisenatide, insulin glargine or to any of the inactive ingredients in the formulation
• History of drug or alcohol abuse within 6 months prior to screening visit

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iGlarLixi	iGlarLixi (insulin glargine/lixisenatide)	iGlarLixi will be administered to study participants subcutaneously

Primary Outcome Measures

Name	Time	Method
Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)	From Day 1 to Week 25

Secondary Outcome Measures

Name	Time	Method
Mean change in hemoglobin A1c (HbA1c)	From baseline to the end of 6 months
Mean change in fasting plasma glucose (FPG)	From baseline to the end of 3 months and 6 months
Mean change in 2 hours postprandial plasma glucose (PPG)	From baseline to the end of 3 months and 6 months
Mean change in fasting Self-Monitoring Plasma Glucose (SMPG)	From baseline to the end of 3 months and 6 months
Change in mean dose of iGlarLixi	From baseline to the end of 6 months
Effect of iGlarLixi on 7-point Self-Monitoring Plasma Glucose (SMPG) profile	From baseline to the end of 3 months and 6 months
Mean change in bodyweight	From baseline to the end of 6 months
Percentage of participants with at least one hypoglycaemic episode	From Day 1 to Week 25	Hypoglycaemic episodes: American Diabetes Association (ADA) level 1, 2 or 3

Trial Locations

Locations (6)

Investigational Site Number : 3560003; 🇮🇳 Kanpur, India

Investigational Site Number : 3560007; 🇮🇳 Delhi, India

Investigational Site Number : 3560005; 🇮🇳 Hyderabad, India

Investigational Site Number : 3560011; 🇮🇳 Jaipur, India

Investigational Site Number : 3560001; 🇮🇳 Kolkata, India

Investigational Site Number : 3560008; 🇮🇳 Pune, India