A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Overview
- Phase
- Phase 3
- Intervention
- metformin hydrochloride
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 1217
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change in HbA1c Levels
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 Diabetes
- •Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
- •HbA1c \>6.5% and \</=10%
Exclusion Criteria
- •Type 1 Diabetes
- •Insulin therapy within one year of enrolment
- •Renal (kidney) failure or dysfunction
Arms & Interventions
1
dapagliflozin plus metformin
Intervention: metformin hydrochloride
1
dapagliflozin plus metformin
Intervention: dapagliflozin
2
glipizide plus metformin
Intervention: glipizide
2
glipizide plus metformin
Intervention: metformin hydrochloride
Outcomes
Primary Outcomes
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 52
To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.
Secondary Outcomes
- Adjusted Mean Change in Body Weight(Baseline to Week 52)
- Proportion of Participants With Body Weight Reduction of at Least 5%(Baseline to Week 52)
- Proportion of Participants With at Least One Episode of Hypoglycemia(Baseline to Week 52)