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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00931372

Acronym

RESTORE

Enrollment

Registered

2009-07-02

Start date

2009-06-30

Completion date

2009-08-31

Last updated

2012-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Insulin release, Diabetes mellitus type 2, GLP-1 agonist

Brief summary

The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.

Interventions

DRUGLixisenatide (AVE0010)

Solution for subcutaneous injection 100 µg/mL

DRUGPlacebo

Subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
Area under the insulin secretion curve	within 10 minutes after I.V. glucose challenge

Secondary

Measure	Time frame
Area under the insulin secretion curve	within 10 to 120 minutes after I.V. glucose challenge

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026