GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 4

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

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

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

105

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7.5-10.5%

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06716424

Org study IDLPS18016

Secondary IDU1111-1303-3494ICTRP

Timeline

Milestones

Study first posted2024-12-04actual

Study start2025-01-06actual

Last update posted2026-04-08actual

Primary completion2026-06-26estimated

Study completion2026-06-26estimated

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Mean change in bodyweight

Time frame:From baseline to the end of 6 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

Mean change in hemoglobin A1c (HbA1c)

Time frame:From baseline to the end of 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean change in fasting plasma glucose (FPG)

Time frame:From baseline to the end of 3 months and 6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean change in 2 hours postprandial plasma glucose (PPG)

Time frame:From baseline to the end of 3 months and 6 months

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Mean change in fasting Self-Monitoring Plasma Glucose (SMPG)

Time frame:From baseline to the end of 3 months and 6 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

Time frame:From Day 1 to Week 25

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Percentage of participants with at least one hypoglycaemic episode

Time frame:From Day 1 to Week 25

Documented hypoglycemia

threshold achievement, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in mean dose of iGlarLixi

Time frame:From baseline to the end of 6 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.