- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855166
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
August 9, 2013 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
182
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Blagoevgrad, Bulgaria
- Research Site
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Sofia, Bulgaria
- Research Site
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Beroun, Czech Republic
- Research Site
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Brno, Czech Republic
- Research Site
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Praha, Czech Republic
- Research Site
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Semily, Czech Republic
- Research Site
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Slany, Czech Republic
- Research Site
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Balatonfured, Hungary
- Research Site
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Budapest, Hungary
- Research Site
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Csongrad, Hungary
- Research Site
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Kecskemet, Hungary
- Research Site
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TAT, Hungary
- Research Site
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Elblag, Poland
- Research Site
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Krakow, Poland
- Research Site
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Torun, Poland
- Research Site
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Goteborg, Sweden
- Research Site
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Jarfalla, Sweden
- Research Site
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Lund, Sweden
- Research Site
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Malmo, Sweden
- Research Site
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Stockholm, Sweden
- Research Site
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Uppsala, Sweden
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Dapagliflozin 10 mg plus Metformin
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Tablet oral 10 mg total daily dose once daily 102 weeks
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Tablet oral 100 mg total daily dose once daily rescue medication
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Placebo Comparator: B
Placebo plus Metformin
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Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Tablet oral 100 mg total daily dose once daily rescue medication
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change in Total Body Weight
Time Frame: Baseline to Week 24
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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.
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Baseline to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change in Waist Circumference
Time Frame: Baseline to Week 24
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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.
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Baseline to Week 24
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Adjusted Mean Change in Body Fat Mass
Time Frame: Baseline to Week 24
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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.
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Baseline to Week 24
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Proportion of Participants With Body Weight Decrease ≥5%
Time Frame: Baseline to Week 24
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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.
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Baseline to Week 24
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4)
Time Frame: Baseline to Week 102
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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.
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Baseline to Week 102
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Adjusted Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Time Frame: Baseline to Week 102
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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.
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Baseline to Week 102
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Adjusted Percent Change in Bone Mineral Density (BMD) at Total Hip
Time Frame: Baseline to Week 102
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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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Baseline to Week 102
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jan Bolinder, MD, PhD, Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
- Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.
- Ljunggren O, Bolinder J, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin has no effect on markers of bone formation and resorption or bone mineral density in patients with inadequately controlled type 2 diabetes mellitus on metformin. Diabetes Obes Metab. 2012 Nov;14(11):990-9. doi: 10.1111/j.1463-1326.2012.01630.x. Epub 2012 Jun 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
March 3, 2009
First Posted (Estimate)
March 4, 2009
Study Record Updates
Last Update Posted (Estimate)
October 14, 2013
Last Update Submitted That Met QC Criteria
August 9, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Body Weight
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Dapagliflozin
- Metformin
- Sitagliptin Phosphate
Other Study ID Numbers
- D1690C00012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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