GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

247

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 19-40•HbA1c ≥7.5%

Primary endpoint

•HbA1c, change

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 IDNCT03529123

Org study IDINSLIL08556

Secondary IDU1111-1200-1162UTN

Timeline

Milestones

Study first posted2018-05-18actual

Study start2018-06-19actual

Primary completion2019-11-25actual

Study completion2019-11-25actual

Last update posted2022-04-25actual

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit,

•At screening:

•Age should be ≥ 18 years of age to < 65 years;

•Glycosylated hemoglobin (HbA1c) at screening visit ≥ 7.5% or ≤ 10%;

•Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2.

•Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable.

Exclusion criteria

•Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening.

•Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator).

•For patients taking metformin, any contraindication to metformin use, according to local labeling.

•For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.

•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).

•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.

•History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.

•Average insulin glargine daily dose <20 U or >50 U calculated for the last 3 days before Visit 6.

•Amylase and/or lipase >3 upper limit normal (ULN) at Visit 5 (Week -1).

The above information is not intended to contain all considerations relevant to a patient'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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline to Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change in HbA1c

Time frame:From baseline to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Patients with HbA1c <7%

Time frame:At Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in 2-hour Post prandial glucose (PPG)

Time frame:From baseline to Week 24

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Patients with HbA1c <7% with no body weight gain and no hypoglycemia

Time frame:At Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:From baseline to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Patients with HbA1c <7% with no body weight gain

Time frame:At Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Change in SMPG profiles

Time frame:From baseline to Week 24

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events (AE)

Time frame:Up to 33 weeks

Treatment-emergent AEs (any)

event count, event

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.