Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00855166 |
Recruitment Status :
Completed
First Posted : March 4, 2009
Results First Posted : October 14, 2013
Last Update Posted : October 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: Dapagliflozin Drug: Metformin Drug: Sitagliptin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 182 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Dapagliflozin 10 mg plus Metformin
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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
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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 |
- Adjusted Mean Change in Total Body Weight [ Time Frame: Baseline to Week 24 ]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.
- Adjusted Mean Change in Waist Circumference [ Time Frame: Baseline to Week 24 ]To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.
- Adjusted Mean Change in Body Fat Mass [ Time Frame: Baseline to Week 24 ]To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry.
- Proportion of Participants With Body Weight Decrease ≥5% [ Time Frame: Baseline to Week 24 ]To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.
- Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4) [ Time Frame: Baseline to Week 102 ]To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.
- Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck [ Time Frame: Baseline to Week 102 ]To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.
- Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip [ Time Frame: Baseline to Week 102 ]To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00855166
Bulgaria | |
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Blagoevgrad, Bulgaria | |
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Sofia, Bulgaria | |
Czech Republic | |
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Beroun, Czech Republic | |
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Brno, Czech Republic | |
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Praha, Czech Republic | |
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Semily, Czech Republic | |
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Slany, Czech Republic | |
Hungary | |
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Balatonfured, Hungary | |
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Budapest, Hungary | |
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Csongrad, Hungary | |
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Kecskemet, Hungary | |
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TAT, Hungary | |
Poland | |
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Elblag, Poland | |
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Krakow, Poland | |
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Torun, Poland | |
Sweden | |
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Goteborg, Sweden | |
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Jarfalla, Sweden | |
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Lund, Sweden | |
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Malmo, Sweden | |
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Stockholm, Sweden | |
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Uppsala, Sweden |
Principal Investigator: | Jan Bolinder, MD, PhD | Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00855166 |
Other Study ID Numbers: |
D1690C00012 |
First Posted: | March 4, 2009 Key Record Dates |
Results First Posted: | October 14, 2013 |
Last Update Posted: | October 14, 2013 |
Last Verified: | August 2013 |
Dapagliflozin Metformin Type 2 diabetes body weight |
Diabetes Mellitus Diabetes Mellitus, Type 2 Body Weight Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Sitagliptin Phosphate Dapagliflozin Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Sodium-Glucose Transporter 2 Inhibitors |