GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Sanofi

Assets

Liraglutide / SAR425899

Listed sites

Recruiting sites

—

Enrollment

296

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

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 IDNCT02973321

Org study IDDRI13940

Secondary ID2016-001328-77

Secondary IDU1111-1179-4786UTN

Timeline

Milestones

Study first posted2016-11-25estimated

Study start2016-12-02actual

Primary completion2017-12-27actual

Study completion2017-12-27actual

Results first posted2021-02-09actual

Last update posted2022-03-24actual

Assets

Investigational agents

Liraglutide SAR425899

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit.

•On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.

•Signed informed consent.

Exclusion criteria

•At screening, participant's age < legal age of adulthood and >80 years.

•Glycated hemoglobin at screening visit <7.0% or >10.0%.

•Body mass index (BMI) <25 kg/m^2 or >45.0 kg/m^2.

•Pregnant or lactating women.

•Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.

•Diagnosis of type 1 diabetes mellitus.

•Fasting plasma glucose of >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.

•Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.

•Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.

•Contraindication(s) to metformin use.

•Contraindication(s) to liraglutide use.

•Significant change in body weight in the 3 months before screening.

•Poorly controlled hypertension (a resting systolic blood pressure (SBP) >160 mm Hg and/or diastolic blood pressure (DBP) >95 mm Hg at screening).

•History of long QT syndrome and/or QTc more than 450 ms at screening visit.

•History of pancreatitis or pancreatectomy.

•History of weight loss surgery.

•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.

•Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.

•Contraindications or known hypersensitivity reaction to glucagon.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Endpoints (20)

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

6 endpoints

Secondary/registry result

Mean Change From Baseline in Body Weight to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kg	95% CI
Placebo	-1.759	—
SAR425899 0.12 mg	-4.276	—
SAR425899 0.16 mg	-5.330	—
SAR425899 0.20 mg	-4.407	—
Liraglutide	-4.590	—

p0.0012ANCOVA

LS Mean difference-3.5795% CI-5.309 – -1.832p< 0.0001ANCOVA

LS Mean difference-2.51795% CI-4.264 – -0.77p0.0047ANCOVA

Secondary/registry result

Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
PlaceboParticipants Achieving >=5% Body Weight Loss	3.0	—
Participants Achieving >=10% Body Weight Loss	0.0	—
SAR425899 0.12 mgParticipants Achieving >=5% Body Weight Loss	33.3	—
Participants Achieving >=10% Body Weight Loss	12.1	—
SAR425899 0.16 mgParticipants Achieving >=5% Body Weight Loss	45.5	—
Participants Achieving >=10% Body Weight Loss	13.6	—
SAR425899 0.20 mgParticipants Achieving >=5% Body Weight Loss	35.9	—
Participants Achieving >=10% Body Weight Loss	15.6	—
LiraglutideParticipants Achieving >=5% Body Weight Loss	40.3	—
Participants Achieving >=10% Body Weight Loss	9.0	—

Secondary/registry result

Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences

Time frame:Baseline,Week 26

Waist circumference, change

change from baseline, improvement

componentsWaist circumference, change, other:hip circumference change

Posted result

Group	Value (mean), cm	95% CI
PlaceboWaist Circumference	-2.0	—
Hip Circumference	-1.42	—
SAR425899 0.12 mgWaist Circumference	-5.3	—
Hip Circumference	-4.46	—
SAR425899 0.16 mgWaist Circumference	-2.3	—
Hip Circumference	-1.97	—
SAR425899 0.20 mgWaist Circumference	-3.2	—
Hip Circumference	-4.09	—
LiraglutideWaist Circumference	-4.0	—
Hip Circumference	-2.56	—

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight to Week 26

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving >=5% or >=10% Body Weight Loss at Week 26

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Pharmacodynamic Biomarkers to Week 26 - Waist and Hip Circumferences

Time frame:Baseline,Week 26

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints

Primary/registry result

Change From Baseline in HbA1c to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Placebo	-0.663	—
SAR425899 0.12 mg	-1.517	—
SAR425899 0.16 mg	-1.618	—
SAR425899 0.20 mg	-1.562	—
Liraglutide	-1.312	—

p< 0.0001ANCOVA

LS Mean difference-0.95695% CI-1.359 – -0.552p< 0.0001ANCOVA

LS Mean difference-0.85495% CI-1.264 – -0.444p< 0.0001ANCOVA

Primary/protocol endpoint

Change From Baseline in HbA1c to Week 26

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
PlaceboParticipants with HbA1c Target of <6.5%	12.1	—
Participants with HbA1c Target of <7%	36.4	—
SAR425899 0.12 mgParticipants with HbA1c Target of <6.5%	47.0	—
Participants with HbA1c Target of <7%	66.7	—
SAR425899 0.16 mgParticipants with HbA1c Target of <6.5%	51.5	—
Participants with HbA1c Target of <7%	68.2	—
SAR425899 0.20 mgParticipants with HbA1c Target of <6.5%	48.4	—
Participants with HbA1c Target of <7%	65.6	—
LiraglutideParticipants with HbA1c Target of <6.5%	44.8	—
Participants with HbA1c Target of <7%	67.2	—

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Placebo	-0.931	—
SAR425899 0.12 mg	-2.408	—
SAR425899 0.16 mg	-2.548	—
SAR425899 0.20 mg	-2.318	—
Liraglutide	-2.124	—

Secondary/registry result

Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Placebo	-1.82	—
SAR425899 0.12 mg	-2.86	—
SAR425899 0.16 mg	-2.63	—
SAR425899 0.20 mg	-2.49	—
Liraglutide	-2.21	—

Secondary/registry result

Percentage of Participants Requiring Rescue Therapy

Time frame:Baseline up to 26 weeks

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Placebo	18.2	—
SAR425899 0.12 mg	0.0	—
SAR425899 0.16 mg	1.5	—
SAR425899 0.20 mg	3.1	—
Liraglutide	6.0	—

Secondary/registry result

Change From Baseline in Beta-Cell Function to Week 26

Time frame:Baseline, Week 26

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of normal beta cells function	95% CI
Placebo	15.025	—
SAR425899 0.12 mg	26.768	—
SAR425899 0.16 mg	31.122	—
SAR425899 0.20 mg	17.932	—
Liraglutide	27.263	—

Secondary/registry result

Change From Baseline in Insulin Resistance to Week 26

Time frame:Baseline, Week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), HOMA-IR Index	95% CI
Placebo	-1.315	—
SAR425899 0.12 mg	-1.244	—
SAR425899 0.16 mg	-2.233	—
SAR425899 0.20 mg	-2.324	—
Liraglutide	-1.405	—

Secondary/protocol endpoint

Percentage of Participants Reached HbA1c Target of <6.5% or <7% at Week 26

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26

Time frame:Baseline, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Average 7 Point Self-Monitoring Plasma Glucose (SMPG) to Week 26

Time frame:Baseline, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Requiring Rescue Therapy

Time frame:Baseline up to 26 weeks

threshold achievement, event

Secondary/protocol endpoint

Change From Baseline in Beta-Cell Function to Week 26

Time frame:Baseline, Week 26

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Resistance to Week 26

Time frame:Baseline, Week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Improved postprandial glucose metabolism in type 2 diabetes by the dual glucagon-like peptide-1/glucagon receptor agonist SAR425899 in comparison with liraglutide.
Diabetes, obesity & metabolism2021 Aug (month)PMID33822469doi:10.1111/dom.14394via clinicaltrials gov reference derived + pubmed nct search
Development and First Use of the Patient's Qualitative Assessment of Treatment (PQAT) Questionnaire in Type 2 Diabetes Mellitus to Explore Individualised Benefit-Harm of Drugs Received During Clinical Studies.
Drug safety2020 Feb (month)PMID31679129doi:10.1007/s40264-019-00877-4via clinicaltrials gov reference derived + pubmed nct search

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.