Insulin Glulisine in Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00297583
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of the study was to compare the effect of insulin glulisine, insulin lispro and unmodified human insulin on endogenous glucose production during euglycemic glucose clamps using stable labeled glucose in type 1 diabetic subjects.

The secondary objectives of the study were to assess:

* the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma nonesterified free fatty acids (NEFA) and glycerol levels

* the effect of insulin glulisine, insulin lispro and unmodified human insulin on plasma lactate levels

* the safety and tolerability of insulin glulisine in comparison to insulin lispro and unmodified human insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2004-05
• Study First Submitted: 2006-02-20
• Study First Submitted QC: 2006-02-27
• Study First Posted: 2006-02-28
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
serum insulin concentrations	During the Study Conduct

Secondary Outcome Measures

Name	Time	Method
glucose infusion rates	During the study conduct
blood glucose concentrations	During the study conduct
Adverse events and hypoglycemic episodes collection	from the inform consnet signed up to the end of the study