A 24-Week,Int.,Rand.,Double-blind,Parallel-group,Multi-centre, Plac.-Controlled Phase III Study With a 24-Wk Ext.Per.to Eval.the Efficacy and Safety of Dapagliflozin in Comb.With Glimepiride (a Sulphonylurea) in Subjects With Type2 Diab.Who Have Inadeq. Glycaemic Control on Glimepiride Therapy Alone
Overview
- Phase
- Phase 3
- Intervention
- dapagliflozin
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 597
- 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 glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 Diabetes
- •Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
- •Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%
Exclusion Criteria
- •Type 1 Diabetes
- •Hepatic (liver) impairment
- •Renal (kidney) failure or dysfunction
Arms & Interventions
1
dapagliflozin 2.5mg + Glimepiride
Intervention: dapagliflozin
1
dapagliflozin 2.5mg + Glimepiride
Intervention: Glimepiride
1
dapagliflozin 2.5mg + Glimepiride
Intervention: metformin hydrochloride
1
dapagliflozin 2.5mg + Glimepiride
Intervention: pioglitazone hydrochloride
1
dapagliflozin 2.5mg + Glimepiride
Intervention: Rosiglitazone
2
dapagliflozin 5mg + Glimepiride
Intervention: dapagliflozin
2
dapagliflozin 5mg + Glimepiride
Intervention: Glimepiride
2
dapagliflozin 5mg + Glimepiride
Intervention: metformin hydrochloride
2
dapagliflozin 5mg + Glimepiride
Intervention: pioglitazone hydrochloride
2
dapagliflozin 5mg + Glimepiride
Intervention: Rosiglitazone
3
dapagliflozin 10mg + Glimepiride
Intervention: dapagliflozin
3
dapagliflozin 10mg + Glimepiride
Intervention: Glimepiride
3
dapagliflozin 10mg + Glimepiride
Intervention: metformin hydrochloride
3
dapagliflozin 10mg + Glimepiride
Intervention: pioglitazone hydrochloride
3
dapagliflozin 10mg + Glimepiride
Intervention: Rosiglitazone
4
Placebo + Glimepiride
Intervention: Glimepiride
4
Placebo + Glimepiride
Intervention: metformin hydrochloride
4
Placebo + Glimepiride
Intervention: pioglitazone hydrochloride
4
Placebo + Glimepiride
Intervention: Rosiglitazone
Outcomes
Primary Outcomes
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 24
To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.
Secondary Outcomes
- Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%(At Week 24)
- Adjusted Mean Change in Body Weight(Baseline to Week 24)
- Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise(Baseline to Week 24)
- Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2(Baseline to Week 24)
- Adjusted Mean Change in Fasting Plasma Glucose (FPG)(Baseline to Week 24)