Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Dapagliflozin
Drug: Metformin
Drug: Sitagliptin
Drug: Placebo
PhasePhase 3
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00855166
First ReceivedMarch 3, 2009
Last UpdatedAugust 9, 2013
Last verifiedAugust 2013

Tracking Information[ + expand ][ + ]

First Received DateMarch 3, 2009
Last Updated DateAugust 9, 2013
Start DateFebruary 2009
Estimated Primary Completion DateDecember 2011
Current Primary Outcome MeasuresAdjusted 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.
Current 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.

Descriptive Information[ + expand ][ + ]

Brief TitleEvaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
Official TitleA 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: 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
Study Arm (s)
  • Experimental: A
    Dapagliflozin 10 mg plus Metformin
  • Placebo Comparator: B
    Placebo plus Metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment182
Estimated Completion DateDecember 2011
Estimated Primary Completion DateJune 2010
Eligibility 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
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesBulgaria, Czech Republic, Hungary, Poland, Sweden

Administrative Information[ + expand ][ + ]

NCT Number NCT00855166
Other Study ID NumbersD1690C00012
Has Data Monitoring CommitteeYes
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsBristol-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
Verification DateAugust 2013

Locations[ + expand ][ + ]

Research Site
Blagoevgrad, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
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
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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
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Elblag, Poland
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Krakow, Poland
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Torun, Poland
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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