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

NCT06716424 | Active Not Recruiting Phase 4

• 2 other identifiers: LPS18016U1111-1303-3494
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 10

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes mellitus; Soliqua; iGlarLixi

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)

  From Day 1 to Week 25

Secondary Outcomes (8)

• 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

Study Arms (1)

iGlarLixi

EXPERIMENTAL

iGlarLixi will be administered to study participants subcutaneously

Drug: iGlarLixi (insulin glargine/lixisenatide)

Interventions

iGlarLixi (insulin glargine/lixisenatide) DRUG

iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously

Also known as: Soliqua®, Solostar®

iGlarLixi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (10)

Investigational Site Number : 3560009

Bengaluru, 560054, India

Location

Investigational Site Number : 3560007

Delhi, 110088, India

Location

Investigational Site Number : 3560005

Hyderabad, 500034, India

Location

Investigational Site Number : 3560006

Indore, 452010, India

Location

Investigational Site Number : 3560011

Jaipur, 302020, India

Location

Investigational Site Number : 3560003

Kanpur, 208002, India

Location

Investigational Site Number : 3560001

Kolkata, 700020, India

Location

Investigational Site Number : 3560008

Pune, 411004, India

Location

Investigational Site Number: 3560013

Pune, 411057, India

Location

Investigational Site Number : 3560014

Visakhapatnam, 530040, India

Location

Related Links

• LPS18016 Plain Language Results Summary

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: January 6, 2025
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (10)