Evaluation of Efficacy and Safety of HMR1964 (Insulin Glulisine) in Subjects With Type 1 Diabetes Mellitus; Insulin Lispro Controlled, Open, Randomized, Parallel Group, Non-inferiority Study, for 28 Weeks

NCT00290979 Phase 3 COMPLETED

* To evaluate non-inferiority in the efficacy of HMR1964 as compared with Insulin lispro in terms of the change in HbA1C from baseline to endpoint. * To compare the safety of HMR1964 with insulin lispro.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	250
Start date	2004-12

Conditions

• Diabetes Mellitus, Type 1

Interventions

• insulin glulisine

Primary outcomes

• Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro

Countries

Japan