Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Dapagliflozin Drug: Metformin Drug: Sitagliptin Drug: Placebo |
Phase | Phase 3 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00855166 |
First Received | March 3, 2009 |
Last Updated | August 9, 2013 |
Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | March 3, 2009 |
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Last Updated Date | August 9, 2013 |
Start Date | February 2009 |
Estimated Primary Completion Date | December 2011 |
Current Primary Outcome Measures | Adjusted Mean Change in Total Body Weight [Time Frame: Baseline to Week 24] [Designated as safety issue: No]To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes |
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Official Title | A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone |
Brief Summary | This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Dapagliflozin Tablet oral 10 mg total daily dose once daily 102 weeks Drug: Metformin Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks Drug: Sitagliptin Tablet oral 100 mg total daily dose once daily rescue medication Drug: Placebo Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 182 |
Estimated Completion Date | December 2011 |
Estimated Primary Completion Date | June 2010 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes - Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment - Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5% - ≥30 years for males - ≥55 years for females Exclusion Criteria: - Type 1 Diabetes - Body weight change >5% within 3 months prior to enrolment - Renal and liver impairment |
Gender | Both |
Ages | 30 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Bulgaria, Czech Republic, Hungary, Poland, Sweden |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00855166 |
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Other Study ID Numbers | D1690C00012 |
Has Data Monitoring Committee | Yes |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Bristol-Myers Squibb |
Investigators | Principal Investigator: Jan Bolinder, MD, PhD Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden |
Verification Date | August 2013 |
Locations[ + expand ][ + ]
Research Site | Blagoevgrad, Bulgaria |
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Research Site | Sofia, Bulgaria |
Research Site | Beroun, Czech Republic |
Research Site | Brno, Czech Republic |
Research Site | Praha, Czech Republic |
Research Site | Semily, Czech Republic |
Research Site | Slany, Czech Republic |
Research Site | Balatonfured, Hungary |
Research Site | Budapest, Hungary |
Research Site | Csongrad, Hungary |
Research Site | Kecskemet, Hungary |
Research Site | TAT, Hungary |
Research Site | Elblag, Poland |
Research Site | Krakow, Poland |
Research Site | Torun, Poland |
Research Site | Goteborg, Sweden |
Research Site | Jarfalla, Sweden |
Research Site | Lund, Sweden |
Research Site | Malmo, Sweden |
Research Site | Stockholm, Sweden |
Research Site | Uppsala, Sweden |