A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin
Overview
- Phase
- Phase 3
- Intervention
- Dapagliflozin
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 1240
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change in HbA1c Levels
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study is being carried out to see if Dapagliflozin in addition to insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 Diabetes
- •Patients with HbA1c ≥7.5% and ≤10.5% and who are on a stable insulin regimen of at least 30 IU of injectable insulin per day either without any other oral antidiabetic drug or with a stable dose of oral antidiabetic drugs
Exclusion Criteria
- •Type 1 Diabetes
- •Treatment with more than two additional oral antidiabetic drugs
- •Moderate and severe renal (kidney) failure or dysfunction
Arms & Interventions
1
2.5mg
Intervention: Dapagliflozin
2
5mg
Intervention: Dapagliflozin
3
10mg
Intervention: Dapagliflozin
4
Intervention: Placebo
Outcomes
Primary Outcomes
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 24
To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.
Secondary Outcomes
- Proportion of Participants With Calculated Mean Daily Insulin Dose Reduction(Baseline to Week 24)
- Adjusted Mean Change in Body Weight(Baseline to Week 24)
- Adjusted Mean Change in Calculated Mean Daily Insulin Dose(Baseline to Week 24)
- Adjusted Mean Change in Fasting Plasma Glucose (FPG)(Baseline to Week 24)