Who is sponsoring NCT01195454?

NCT01195454 is sponsored by Sanofi.

What condition does NCT01195454 study?

NCT01195454 studies Type 1 Diabetes Mellitus.

What drugs are being tested in NCT01195454?

Interventions: Insulin glargine (HOE901), Insulin glargine (HOE901).

What is the status of NCT01195454?

NCT01195454 is currently COMPLETED.

Last reviewed 2011-10-28 · How we verify

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

NCT01195454 Phase 1 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2010-08
Completion	2010-12

Conditions

Type 1 Diabetes Mellitus

Interventions

Insulin glargine (HOE901)
Insulin glargine (HOE901)

Primary outcomes

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

Countries

Germany