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

March 3, 2009
August 9, 2013
February 2009
June 2010   (final data collection date for primary outcome measure)
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.
Change in body weight [ Time Frame: from baseline to week 24 and to week 102 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00855166 on ClinicalTrials.gov Archive Site
  • 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.
  • Change in waist circumference [ Time Frame: from baseline to week 24 and to week 102 ] [ Designated as safety issue: No ]
  • Change in body fat mass measured by Dual Energy X-ray Absorptiometry [ Time Frame: from baseline to week 24 and to week 102 ] [ Designated as safety issue: No ]
  • Percent change in bone mineral density at lumbar spine, femoral neck and total hip [ Time Frame: from baseline at 50 and 102 weeks ] [ Designated as safety issue: No ]
  • 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.
Not Provided
 
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • 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
  • Drug: Placebo
    Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
  • Experimental: A
    Dapagliflozin 10 mg plus Metformin
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Metformin
    • Drug: Sitagliptin
  • Placebo Comparator: B
    Placebo plus Metformin
    Interventions:
    • Drug: Metformin
    • Drug: Sitagliptin
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
December 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Czech Republic,   Hungary,   Poland,   Sweden
 
NCT00855166
D1690C00012
Yes
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Principal Investigator: Jan Bolinder, MD, PhD Dept of Endocrinology, Metabolism and Diabetes Karolinska University Hospital Huddinge Karolinska Institutet 141 86 Stockholm Sweden
AstraZeneca
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP