Efficacy and Safety of Insulin Glulisine in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00290979|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : August 26, 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: insulin glulisine||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
- Non-inferiority in the efficacy and safety of HMR1964 as compared with Insulin lispro
- 6-month safety data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290979
|Study Director:||Masayoshi KOYAMA||Sanofi|