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:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00855166
First received: March 3, 2009
Last updated: August 9, 2013
Last verified: August 2013
  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:
  • 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.


Secondary Outcome Measures:
  • Adjusted Mean Change in Waist Circumference [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Adjusted Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-4) [ Time Frame: Baseline to Week 102 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: January 21, 2013
Last Updated: August 9, 2013
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014