Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00855166
First received: March 3, 2009
Last updated: January 9, 2012
Last verified: January 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Dapagliflozin Drug: Metformin Drug: Sitagliptin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change in body weight [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in waist circumference [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
- Change in body fat mass measured by Dual Energy X-ray Absorptiometry [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
- Proportion of subjects with body weight decrease ≥5% [ Time Frame: from baseline to weeks 24 ] [ Designated as safety issue: No ]
| Enrollment: | 182 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Dapagliflozin 10 mg plus Metformin
|
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
|
|
Placebo Comparator: B
Placebo plus Metformin
|
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
|
Eligibility| Ages Eligible for Study: | 30 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855166
Locations
| Bulgaria | |
| Research Site | |
| Blagoevgrad, Bulgaria | |
| Research Site | |
| Sofia, Bulgaria | |
| Czech Republic | |
| 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 | |
| Hungary | |
| Research Site | |
| Balatonfured, Hungary | |
| Research Site | |
| Budapest, Hungary | |
| Research Site | |
| Csongrad, Hungary | |
| Research Site | |
| Kecskemet, Hungary | |
| Research Site | |
| TAT, Hungary | |
| Poland | |
| Research Site | |
| Elblag, Poland | |
| Research Site | |
| Krakow, Poland | |
| Research Site | |
| Torun, Poland | |
| Sweden | |
| Research Site | |
| Goteborg, Sweden | |
| Research Site | |
| Jarfalla, Sweden | |
| Research Site | |
| Lund, Sweden | |
| Research Site | |
| Malmo, Sweden | |
| Research Site | |
| Stockholm, Sweden | |
| Research Site | |
| Uppsala, Sweden | |
Sponsors and Collaborators
AstraZeneca
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 |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00855166 History of Changes |
| Other Study ID Numbers: | D1690C00012 |
| Study First Received: | March 3, 2009 |
| Last Updated: | January 9, 2012 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Poland: Ministry of Health Sweden: Medical Products Agency |
Keywords provided by AstraZeneca:
|
Dapagliflozin Metformin Type 2 diabetes body weight |
Additional relevant MeSH terms:
|
Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013