Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
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|ClinicalTrials.gov Identifier: NCT00358124|
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: insulin glargine Drug: rosiglitazone Drug: metformin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2001|
|Study Completion Date :||June 2002|
- The primary efficacy variable was the change in HbA1C from baseline to the end of therapy.
- Other efficacy variables were the change from baseline in FPG, serum lipids and weight.
- Secondary efficacy parameters were: a mean change from baseline in FPG
- Mean change from baseline in fasting insulin/C-peptide levels
- Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids)
- Mean change from baseline for bodyweight.
- Health-related quality of life was compared between the baseline visit and the follow-up assessments
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): NCT00358124
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Karen Barch||Sanofi|