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).
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): NCT00290927
|Study Director:||Masayoshi KOYAMA||Sanofi|