DRUG
iGlarLixi (insulin glargine/lixisenatide)
iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously
Status
Completed
Phase
Phase 4
Enrollment
105
Locations
10
Results
Not posted
Publications
0
Study 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.
The study duration will be up to 27 weeks, with a treatment duration approximately 24 weeks.
Interventions
DRUG
iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously
Timeline
First posted
Dec 4, 2024
Study start
Jan 6, 2025
Primary completion
Jun 12, 2026
Study completion
Jun 12, 2026
Results posted
Not reported
Registry updated
Jul 10, 2026
Outcomes
Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)
Time frame · From Day 1 to Week 25
Mean change in hemoglobin A1c (HbA1c)
Time frame · From baseline to the end of 6 months
Mean change in fasting plasma glucose (FPG)
Time frame · From baseline to the end of 3 months and 6 months
Mean change in 2 hours postprandial plasma glucose (PPG)
Time frame · From baseline to the end of 3 months and 6 months
Mean change in fasting Self-Monitoring Plasma Glucose (SMPG)
Time frame · From baseline to the end of 3 months and 6 months
Change in mean dose of iGlarLixi
Time frame · From baseline to the end of 6 months
Effect of iGlarLixi on 7-point Self-Monitoring Plasma Glucose (SMPG) profile
Time frame · From baseline to the end of 3 months and 6 months
Mean change in bodyweight
Time frame · From baseline to the end of 6 months
Percentage of participants with at least one hypoglycaemic episode
Time frame · From Day 1 to Week 25
Hypoglycaemic episodes: American Diabetes Association (ADA) level 1, 2 or 3
Eligibility
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 locations
India. Showing up to 24 locations stored in the fast local snapshot.
Investigational Site Number : 3560009
Bengaluru, India
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
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Shanghai Zhongshan Hospital · Type 2 Diabetes
Phase 4
Recruiting
1,316
2026-07
Brigham and Women's Hospital · Cardiovascular Events · Type2 Diabetes
Not applicable
Active, not recruiting
781,430
2026-05
Sanofi · Type 2 Diabetes (T2D)
Phase 4
Recruiting
678
2026-03
Yanbing Li · Type 2 Diabetes
Phase 4
Not yet recruiting
324
2026-02
University Hospital, Toulouse · Parkinson Disease
Phase 2
Completed
156
2025-11
Sanofi · Type 2 Diabetes Mellitus
Phase 3
Completed
582
2025-09
Ohio State University · Cardiovascular Kidney Metabolic Syndrome
Not applicable
Active, not recruiting
23,280,000
2025-09
Medical University of Warsaw · Steroid-Induced Diabetes · Steroid-Induced Hyperglycemia
Phase 4
Enrolling by invitation
100
2025-09
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.