Study of How Single Rising Doses of SAR161271 Are Absorbed and Act in Patients With Type 1 Diabetes Mellitus (T1DM)

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: SAR161271; Drug: Insulin glargine HOE901

• Registration Number: NCT01053728
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.

Secondary Objective:

- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM

Detailed Description

The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:

* Screening: 3 to 27 days;

* Treatment Periods each 1 day with institutionalisation from Day -1 to Day 3;

* Wash-out between doses: 7 to 10 days;

* End of Study visit: 7 to 10 days after last dose.

* Post-study visit 84 to 112 days after last dosing. If necessary, additional post-study visit 6 to 7 months after last dosing.

Study Timeline

• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-21
• Study Start: 2010-02
• Primary Completion: 2010-05
• Study Completion: 2010-11
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1 : SAR161271 0.3 U/kg	SAR161271	Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cohort 1 : SAR161271 0.3 U/kg	Insulin glargine HOE901	Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cohort 2 : SAR161271 0.6 U/kg	Insulin glargine HOE901	Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cohort 3 : SAR161271 1.2 U/kg	Insulin glargine HOE901	Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cohort 2 : SAR161271 0.6 U/kg	SAR161271	Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Cohort 3 : SAR161271 1.2 U/kg	SAR161271	Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp

Primary Outcome Measures

Name	Time	Method
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort	up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile	up to 30 hours after dose

Secondary Outcome Measures

Name	Time	Method
- anti-insulin antibody production	pre-dose and after 4th dose
- Pharmacokinetic parameters	up to 168 hours after dose

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇩🇪 Berlin, Germany