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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Dapagliflozin Drug: Metformin Drug: Sitagliptin Drug: Placebo Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: March 4, 2009    Key Record Dates
Results First Posted: October 14, 2013
Last Update Posted: October 14, 2013
Last Verified: August 2013

Keywords provided by AstraZeneca:
Dapagliflozin
Metformin
Type 2 diabetes
body weight

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Metformin
Sitagliptin Phosphate
 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