Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Insulin glargine (HOE901)

• Registration Number: NCT01195454
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus®

Secondary Objectives:

* To assess the exposure ratios of a new insulin glargine formulation versus Lantus®

* To compare the duration of action of a new insulin glargine formulation versus Lantus®

* To explore the dose response and dose exposure relationship of a new insulin glargine formulation

* To assess the safety and tolerability of a new insulin glargine formulation

Detailed Description

The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows:

* Screening: 3 to 28 days

* Treatment period: 1 to 4 days: 2 days (1 overnight stay)

* Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)

* End of study: 1 day after the last dosing

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-28
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin glargine / New insulin glargine formulation	Insulin glargine (HOE901)	* Period 1: Insulin glargine * Period 2: New insulin glargine formulation * Period 3: New insulin glargine formulation * Period 4: New insulin glargine formulation Duration of treatment: 1 day at each period

Primary Outcome Measures

Name	Time	Method
The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)	36 hours (D1 to D2) in all four treatment periods

Secondary Outcome Measures

Name	Time	Method
The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -	36 hours (D1 to D2) in all four treatment periods
Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)	36 hours (D1 to D2) in all four treatment periods
Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)	36 hours (D1 to D2) in all four treatment periods
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)	36 hours (D1 to D2) in all four treatment periods
Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)	36 hours (D1 to D2) in all four treatment periods
Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)	36 hours (D1 to D2) in all four treatment periods

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇩🇪 Berlin, Germany