Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00290927|
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : August 26, 2009
- To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
- To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
- To evaluate the safety of HMR1964.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: insulin glulisine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Efficacy and Safety of HMR1964 Intensive Therapy in Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled With Oral Hypoglycemic Agents (OHA); OHA Therapy Controlled, Open, Randomized, Parallel Group, Comparative (Superiority), 16-week, Multinational, Multicenter Study|
|Study Start Date :||December 2003|
- Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy)
- Safety of HMR1964
- change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290927
|Study Director:||Masayoshi KOYAMA||Sanofi|