A 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
Overview
- Phase
- Phase 3
- Intervention
- dapagliflozin
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 400
- 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 - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of informed consent prior to any study specific procedures
- •Diagnosis of T2DM
- •Current antihyperglycaemic treatment with metformin immediate release formulation monotherapy \>/= 1500 mg/day at a stable dose for at least 10 weeks prior to enrolment. Other treatment with OADs within the 10 weeks prior to enrolment is not permitted.
- •HbA1c ≥ 6.7% and ≤10.5%, based on central laboratory values from Screening Visit, and Enrolment Visit 1.
Exclusion Criteria
- •Diagnosis of Type 1 diabetes mellitus, known diagnosis of Maturity Onset Diabetes of the Young (MODY) or secondary causes of diabetes mellitus
- •History of diabetic ketoacidosis
- •Symptoms of poorly controlled diabetes including, but not limited to, marked polyuria, polydipsia, and/or greater than 10% weight loss during the 3 months prior to enrolment
- •FPG \>270 mg/dL (\>15.0 mmol/L)
- •BMI \>45 kg/m2
Arms & Interventions
1
Dapagliflozin 2.5 mg twice-daily plus open-label metformin
Intervention: dapagliflozin
1
Dapagliflozin 2.5 mg twice-daily plus open-label metformin
Intervention: metformin
2
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
Intervention: dapagliflozin
2
Dapagliflozin 5.0 mg twice-daily plus open-label metformin
Intervention: metformin
3
Dapagliflozin 10 mg once-daily plus open-label metformin
Intervention: dapagliflozin
3
Dapagliflozin 10 mg once-daily plus open-label metformin
Intervention: metformin
4
Placebo plus open-label metformin
Intervention: metformin
4
Placebo plus open-label metformin
Intervention: placebo
Outcomes
Primary Outcomes
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 16
To compare the change from baseline in HbA1c achieved with each of the 2 BID doses of dapagliflozin (2.5 mg BID and 5 mg BID) co-administered with metformin versus placebo co-administered with metformin after 16 weeks of double-blind treatment.
Secondary Outcomes
- Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16(Baseline to Week 16)
- Adjusted Percent Change in Body Weight(Baseline to Week 16)
- Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 1(Baseline to Week 1)
- Proportion of Participants With HbA1c<7.0% at Week 16, in Participants Who Had HbA1c ≥7.0% at Baseline.(Baseline to Week 16)