Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
This study has been completed.
Information provided by:
First received: February 10, 2006
Last updated: August 25, 2009
Last verified: March 2009
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro
Secondary Outcome Measures:
- 6-month safety data
|Study Start Date:||December 2004|
- To compare HMR1964 with insulin lispro in terms of the change in HbA1C from baseline to week 12 and week 28; consecutive change in HbA1C by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total).
- To collect 6-month safety data of HMR1964.
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