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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Dapagliflozin; Drug: Metformin; Drug: Placebo; Drug: Sitagliptin

• Registration Number: NCT00855166
• Lead Sponsor: AstraZeneca

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 Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-03-03
• Study First Posted: 2009-03-04
• Primary Completion: 2010-06
• Study Completion: 2011-12
• Results First Submitted: 2013-01-21
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-09
• Last Update Submitted: 2013-08-09
• Results First Posted: 2013-10-14
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Dapagliflozin	Dapagliflozin 10 mg plus Metformin
A	Metformin	Dapagliflozin 10 mg plus Metformin
B	Metformin	Placebo plus Metformin
B	Placebo	Placebo plus Metformin
A	Sitagliptin	Dapagliflozin 10 mg plus Metformin
B	Sitagliptin	Placebo plus Metformin

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in Total Body Weight	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

Name	Time	Method
Adjusted Mean Change in Body Fat Mass	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.
Proportion of Participants With Body Weight Decrease ≥5%	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.
Adjusted Mean Change in Waist Circumference	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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden