Current partner codePEPTIDESDE
NCT06716424·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

105

Locations

10

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full detailed description

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

Interventions

Treatment arms and agents.

DRUG

iGlarLixi (insulin glargine/lixisenatide)

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

Timeline

From registration to results.

  1. First posted

    Dec 4, 2024

  2. Study start

    Jan 6, 2025

  3. Primary completion

    Jun 12, 2026

  4. Study completion

    Jun 12, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 10, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · From Day 1 to Week 25

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

10 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.