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A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE4

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

Multicentre Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA

NCT06716424•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (9)

Investigational Site Number : 3560007

Delhi, India

Investigational Site Number : 3560005

Hyderabad, India

Investigational Site Number : 3560006

Indore, India

Investigational Site Number : 3560011

Jaipur, India

Investigational Site Number : 3560003

Kanpur, India

Investigational Site Number : 3560001

Kolkata, India

Investigational Site Number : 3560008

Pune, India

Investigational Site Number: 3560013

Pune, India

Investigational Site Number : 3560014

Visakhapatnam, India

Key Dates

Start Date

January 6, 2025

Primary Completion Date

June 26, 2026

Completion Date

June 26, 2026

Last Updated

January 21, 2026

Enrollment

105

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

iGlarLixi (insulin glargine/lixisenatide)

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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