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

Sanofi

Status and phase

Active, not recruiting

Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: iGlarLixi (insulin glargine/lixisenatide)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06716424

U1111-1303-3494 (Registry Identifier)

LPS18016

Details and patient eligibility

About

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 description

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

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
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