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

Diabetes Mellitus, Type 2 Clinical Trial

— RESTORE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931372
• Other study ID #: PDY10433
• Secondary ID: EudraCT:2008-003
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2009
• Last updated: February 22, 2012
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Lixisenatide (AVE0010)
Solution for subcutaneous injection 100 µg/mL
• Placebo
Subcutaneous injection

Locations

Country	Name	City	State
Germany	Sanofi-Aventis Administrative Office	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Profil GmbH, Neuss, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin secretion curve		within 10 minutes after I.V. glucose challenge	No
Secondary	Area under the insulin secretion curve		within 10 to 120 minutes after I.V. glucose challenge	No