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
Overview
- Phase
- Phase 3
- Intervention
- Sitagliptin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- AstraZeneca
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change in Total Body Weight
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
A
Dapagliflozin 10 mg plus Metformin
Intervention: Sitagliptin
A
Dapagliflozin 10 mg plus Metformin
Intervention: Dapagliflozin
A
Dapagliflozin 10 mg plus Metformin
Intervention: Metformin
B
Placebo plus Metformin
Intervention: Metformin
B
Placebo plus Metformin
Intervention: Sitagliptin
B
Placebo plus Metformin
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Adjusted Mean Change in Body Fat Mass(Baseline to Week 24)
- Proportion of Participants With Body Weight Decrease ≥5%(Baseline to Week 24)
- Adjusted Mean Change in Waist Circumference(Baseline to Week 24)