A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00263276|
Recruitment Status : Completed
First Posted : December 8, 2005
Last Update Posted : November 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: dapagliflozin Drug: placebo Drug: metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||389 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-512148 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Are Treatment Naive And Have Inadequate Glycemic Control on Diet and Exercise|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
|Experimental: Arm 1||
Tablets, Oral, 2.5 mg, Once daily, 12 weeks.
|Experimental: Arm 2||
Tablets, Oral, 5 mg, Once daily, 12 weeks.
|Experimental: Arm 3||
Tablets, Oral, 10 mg, Once daily, 12 weeks.
|Experimental: Arm 4||
Tablets, Oral, 20 mg, Once daily, 12 weeks.
|Experimental: Arm 5||
Tablets, Oral, 50 mg, Once daily, 12 weeks.
|Placebo Comparator: Arm 6||
Tablets, Oral, 0 mg, Once daily, 12 weeks.
|Active Comparator: Arm 7||
Tablets, Oral, >/= 1500 mg, Once daily, 12 weeks.
- Mean change from baseline in HbA1c compared to placebo. [ Time Frame: at 12 weeks ]
- Mean change from baseline in fasting plasma glucose, evaluate proportion of subjects who achieve a therapeutic response (HbA1c <7%); change from baseline in urinary glucose excretion [ Time Frame: at Weeks 6 and 12 ]
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): NCT00263276
Show 145 Study Locations
|Study Director:||Bristol Myers Squibb||Bristol-Myers Squibb|