Investigating the safety and effectiveness of iGlarLixi for adults with Type 2 diabetes

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

This study is testing if a new combination treatment for Type 2 diabetes can safely help adults manage their blood sugar levels better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Locations: 6 sites (Delhi and 5 other locations)
• Trial ID: NCT06716424 on ClinicalTrials.gov

What this trial studies

This phase IV interventional study aims to evaluate the safety and efficacy of iGlarLixi, a combination of insulin glargine and lixisenatide, in adult patients diagnosed with Type 2 diabetes. The study will last up to 27 weeks, with participants receiving treatment for approximately 24 weeks. Eligible participants must have been diagnosed with Type 2 diabetes for at least one year and have specific HbA1c levels. The study is designed to assess how well this treatment works in managing blood sugar levels in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with Type 2 diabetes who have been on treatment for at least six months and meet specific HbA1c and BMI criteria.

Not a fit: Patients with Type 1 diabetes mellitus will not benefit from this study as it specifically targets Type 2 diabetes.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for adults with Type 2 diabetes, potentially improving their blood sugar control.

How similar studies have performed: Other studies have shown success with similar approaches in managing Type 2 diabetes, indicating that this method is promising.

Eligibility criteria

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.

Where this trial is running

Delhi and 5 other locations

• Investigational Site Number : 3560007 — Delhi, India (Recruiting)
• Investigational Site Number : 3560005 — Hyderabad, India (Recruiting)
• Investigational Site Number : 3560011 — Jaipur, India (Recruiting)
• Investigational Site Number : 3560003 — Kanpur, India (Recruiting)
• Investigational Site Number : 3560001 — Kolkata, India (Recruiting)
• Investigational Site Number : 3560008 — Pune, India (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Type 2 Diabetes; Type 2 diabetes mellitus; Soliqua; iGlarLixi