Who is sponsoring NCT01493115?

NCT01493115 is sponsored by Sanofi.

What condition does NCT01493115 study?

NCT01493115 studies Type 1 Diabetes Mellitus.

What drugs are being tested in NCT01493115?

Interventions: Insulin glargine HOE901, Insulin glargine - New formulation HOE901.

What is the status of NCT01493115?

NCT01493115 is currently COMPLETED.

Last reviewed 2012-04-30 · How we verify

A Randomized, Double-blind, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique

NCT01493115 Phase 1 COMPLETED

Primary Objective: To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® Secondary Objective: To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

Details

Lead sponsor	Sanofi
Phase	Phase 1
Status	COMPLETED
Enrolment	18
Start date	2011-11
Completion	2012-04

Conditions

Type 1 Diabetes Mellitus

Interventions

Insulin glargine HOE901
Insulin glargine - New formulation HOE901

Primary outcomes

Glucose infusion rate — up to day 2 of each period

Countries

Japan