GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

447

actual

Study population

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 IDNCT01632163

Org study IDEFC12382

Secondary IDU1111-1124-1213UTN

Timeline

Milestones

Study first posted2012-07-02estimated

Last update posted2015-06-15estimated

Study start2012-10 (month precision)

Primary completion2015-05actual (month precision)

Study completion2015-05actual (month precision)

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

- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion criteria

At screening:

•Age < legal age of adulthood.

•HbA1c<7% or >10.5%.

•Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.

•If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.

•History of hypoglycemia unawareness.

•Body Mass Index (BMI) ≤20 kg/m².

•Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

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

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

6 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

Percentage of patients with HbA1c <7%, =<6.5%

Time frame:at week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in 2-hour postprandial plasma glucose and plasma glucose excursion

Time frame:from baseline to week 24

Postprandial glucose

change from baseline, improvement

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

Change in 7-point self monitoring plasma glucose profile (average and each point)

Time frame:from baseline to week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in daily basal insulin dose

Time frame:from baseline to week 24

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of patients with adverse events

Time frame:24 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Anti-lixisenatide antibody assessment

Time frame:from baseline to week 24

Immunogenicity (ADA)

descriptive

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

Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2023 Apr (month)PMID36809495doi:10.1007/s13300-023-01369-6via clinicaltrials gov reference derived + pubmed nct search
Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.
Diabetes, obesity & metabolism2018 Feb (month)PMID28742225doi:10.1111/dom.13072via 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 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.