Title
Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
Phase
Phase 3Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Type 2 Diabetes Mellitus High HbA1c Level Inadequate Glycaemic ControlIntervention/Treatment
dapagliflozin ...Study Participants
311This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Inclusion Criteria: Type 2 diabetes mellitus Men or women age ≥ 18 years old Stable dose combination of metformin and sulfonylurea HbA1c ≥7.7% and ≤11.0% Exclusion Criteria: Type 1 diabetes mellitus or diabetes insipidus Recent cardiovascular events Kidney or urological disorders Hepatic disorders
| Event Type | Organ System | Event Term | Placebo Plus Metformin Plus Sulfonylurea | Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea |
|---|
To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.
To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo
To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo
To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo
