GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

24-week Study Comparing Lixisenatide to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 Years

A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

319

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≤50

Primary endpoint

•Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss (HbA1c <7.0% achievement, ≥5% weight-loss responders)

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 IDNCT00976937

Org study IDEFC10780

Secondary IDEudraCT:2008-007 334-22

Timeline

Milestones

Study first posted2009-09-15estimated

Last update posted2016-10-11estimated

Results first posted2016-10-11estimated

Study start2009-08 (month precision)

Primary completion2011-03actual (month precision)

Study completion2011-03actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age49 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus, diagnosed for at least 1 year at the time of screening visit, insufficiently controlled with metformin at a stable dose of at least 1.5 gram/day (g/day) for at least 3 months prior to the screening visit

•Patients with obesity (BMI greater than equal to [>=] 30 kg/m^2) and aged from 18 years to less than 50 years

Exclusion criteria

•HbA1c less than (<) 7.0 percent (%) or HbA1c greater than (>) 10% at screening

•Type 1 diabetes mellitus

•Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method

•FPG at screening >250 milligram/deciliter (mg/dL) (>13.9 millimole/ liter [mmol/L])

•Weight change of more than 5 kg during the 3 months preceding the screening visit

•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (for example, multiple endocrine neoplasia syndromes)

•History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening

•Hemoglobinopathy or hemolytic anemia or receipt of blood or plasma products within 3 months prior to the time of screening

•Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization

•Known history of drug or alcohol abuse within 6 months prior to the time of screening

•Any clinically significant abnormality identified on physical examination, laboratory tests, electrocardiogram (ECG) or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator could have precludes safe completion of the study or constrains efficacy assessment such as major systemic diseases, presence of clinically significant diabetic retinopathy or presence of macular edema likely to require laser treatment within the study period

•Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 millimeter of mercury (mmHg) or >110 mmHg, respectively

•Laboratory findings at the time of screening : Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range; alanine aminotransferase (ALT): >3 times ULN; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin <11 gram/deciliter and/or neutrophils <1500 per cubic millimeter (mm^3) and/or platelets <100 000/mm^3; positive test for Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCAb), positive serum pregnancy test in females of childbearing potential, and calcitonin >=20 picogram per milliliter (pg/mL) (5.9 picomole per liter)

•Patients who are considered by the investigator or any sub-investigator as inappropriate for the study for any reason (for example, impossibility to meet specific protocol requirements [such as scheduled visits, being able to do self-injections], likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, investigator or any sub-investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol)

•Use of other oral or injectable antidiabetic or hypoglycemic agents than metformin (for example, sulfonylurea, alpha glucosidase inhibitor, thiazolidinedione, exenatide, dipeptidyl peptidase IV (DPP-IV) inhibitors, insulin) within 3 months prior to the time of screening

•History of bariatric surgery, anti-obesity treatment, or unstable diet within 3 months prior to the time of screening

•Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening

•Use of any investigational drug within 3 months prior to screening

•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening

•Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)

•Allergic reaction to any glucagon like peptide-1 (GLP 1) agonist in the past (for example, exenatide, liraglutide) or to metacresol

•History of a serious hypersensitivity reaction to sitagliptin

•Moderate or severe renal impairment (creatinine clearance inferior to 50 milliliter/minute [mL/min])

•Additional exclusion criteria at the end of the run-in phase: informed consent withdrawal; lack of compliance during the single-blind placebo run-in period (>2 injections missed or >2 capsules missed); and patient with any adverse event which could have precludes the inclusion in the study, as assessed by the investigator

Endpoints (18)

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

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 24

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram	95% CI
Lixisenatide	-2.51	—
Sitagliptin	-1.17	—

Other/protocol endpoint

Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24

Time frame:Baseline, Week 24

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	18.4	—
Sitagliptin	11.9	—

Glycemic / diabetes

15 endpoints

Primary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% and at Least 5% Weight Loss From Baseline at Week 24

Time frame:Week 24

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	12.0	—
Sitagliptin	7.5	—

Response rate difference4.695% CI-1.84 – 11.00p0.1696Cochran-Mantel-Haenszel

Secondary/protocol endpoint

Absolute Change From Baseline in HbA1c at Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of hemoglobin	95% CI
Lixisenatide	-0.66	—
Sitagliptin	-0.72	—

Secondary/protocol endpoint

Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) at Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-3.35	—
Sitagliptin	-1.44	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-0.45	—
Sitagliptin	-0.69	—

Secondary/protocol endpoint

Change From Baseline in Glucose Excursion at Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lixisenatide	-2.55	—
Sitagliptin	-0.42	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin (PPI) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
LixisenatideFPI (n=119, 133)	-1.70	—
2-hour PPI (n=123, 130)	-57.81	—
SitagliptinFPI (n=119, 133)	-0.88	—
2-hour PPI (n=123, 130)	-2.85	—

Secondary/protocol endpoint

Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24

Time frame:Baseline, Week 24

C-peptide AUC

change from baseline, improvement

componentsC-peptide AUC, C-peptide AUC

Posted result

Group	Value (least_squares_mean), nmol/L	95% CI
LixisenatideFasting C-peptide (n= 123,139)	-0.02	—
2-hour postprandial C-peptide (n=125, 139)	-0.15	—
SitagliptinFasting C-peptide (n= 123,139)	-0.02	—
2-hour postprandial C-peptide (n=125, 139)	0.08	—

Secondary/protocol endpoint

Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ng/L	95% CI
LixisenatideFasting Glucagon (n=124, 138)	1.89	—
2-hour postprandial Glucagon (n=124, 134)	-8.16	—
SitagliptinFasting Glucagon (n=124, 138)	3.52	—
2-hour postprandial Glucagon (n=124, 134)	-4.38	—

Secondary/protocol endpoint

Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
LixisenatideFasting Proinsulin (n=125, 140)	-2.18	—
2-hour postprandial Proinsulin (n=125, 139)	0.28	—
SitagliptinFasting Proinsulin (n=125, 140)	-4.84	—
2-hour postprandial Proinsulin (n=125, 139)	-3.95	—

Secondary/protocol endpoint

Change From Baseline in Insulin Resistance Assessed by Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) at Week 24

Time frame:Baseline, Week 24

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mU * mmol/L^2	95% CI
Lixisenatide	-0.52	—
Sitagliptin	-0.57	—

Secondary/protocol endpoint

Change From Baseline in Beta Cell Function Assessed by Homeostasis Model Assessment-Beta (HOMA-beta) at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of normal beta cells function	95% CI
Lixisenatide	17.66	—
Sitagliptin	17.79	—

Secondary/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	24.0	—
Sitagliptin	26.3	—

Secondary/protocol endpoint

Percentage of Patients Requiring Rescue Therapy During 24-Week Period

Time frame:Baseline up to Week 24

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	9.5	—
Sitagliptin	6.8	—

Other/protocol endpoint

Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Lixisenatide	40.7	—
Sitagliptin	40.0	—

Other/protocol endpoint

Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24

Time frame:Baseline, Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ratio	95% CI
LixisenatideFasting Proinsulin-to-insulin ratio (n=119, 133)	-0.08	—
2-hour PP Proinsulin-to-insulin ratio (n=123, 130)	-0.01	—
SitagliptinFasting Proinsulin-to-insulin ratio (n=119, 133)	-0.17	—
2-hour PP Proinsulin-to-insulin ratio (n=123, 130)	-0.05	—

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 3 days after the last dose administration

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), participants	95% CI
LixisenatideSymptomatic hypoglycemia	1	—
Severe symptomatic hypoglycemia	0	—
SitagliptinSymptomatic hypoglycemia	3	—
Severe symptomatic hypoglycemia	0	—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.