DelfaGLP-1 Atlas

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RESTORE

CompletedPhase 1

Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2

Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

22

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-35•HbA1c 6-8.5%

Primary endpoint

•Area under the insulin secretion curve

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 IDNCT00931372
Org study IDPDY10433
Secondary IDEudraCT:2008-003242-28

Timeline

Milestones

Study first posted2009-07-02estimated
Last update posted2012-02-23estimated
Study start2009-06 (month precision)
Primary completion2009-08actual (month precision)
Study completion2009-08actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

•Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
•HbA1c>=6,0 % and <=8,5 % at screening
•BMI 25 to 35 kg/m²
•155>=BP systolic >=90 mmHg
•100>=BP diastolic>=45 mmHg

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

Endpoints (2)

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.

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint/low confidence

Area under the insulin secretion curve

Time frame:within 10 minutes after I.V. glucose challenge

descriptive

Secondary/protocol endpoint

Area under the insulin secretion curve

Time frame:within 10 to 120 minutes after I.V. glucose challenge

concentration, improvement

Publications (10)

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

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.