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

INTERVENTION: Product Name: Dapagliflozin Product Code: BMS‐512148 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: dapagliflozin Current Sponsor code: BMS‐512148 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Dapaglifozin Product Code: BMS‐512148 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: dapaglifozin Current Sponsor code: BMS‐512148 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Dapaglifozin Product Code: BMS‐512148 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: dapaglifozin Current Sponsor code: BMS‐512148 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Glipizide BP 5 mg Product Name: Glipizide Pharmaceutical Form: Capsule, hard INN or Proposed INN: glipizide CAS Number: 29094‐61‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Type 2 diabetes ; MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non‐insulin‐dependent diabetes mellitus PRIMARY OUTCOME: Main Objective: To examine whether, after 52 weeks of oral administration of double‐blind treatment, the absolute change from baseline in HbA1c level with dapagliflozin plus metformin is non‐inferior to glipizide (sulphonylurea) plus metformin in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.; ; Objectives after the 52‐week extension period:; ‐ To assess the same safety and tolerability parameters as for the first 52 weeks, over 104 weeks treatment; ‐ To assess the maintenance of efficacy of dapagliflozin plus metformin over 104 weeks of treatment Primary end point(s): Primary outcome variable; ‐ Change in HbA1c from baseline to week 52; ; Key secondary outcome variables; ‐ Absolute change in body weight from baseline to week 52; ‐ Proportion of patients reporting at least one episode of hypoglycaemia over 52 weeks; ‐ Proportion of patients with body weight decrease = 5% from baseline to week 52 Secondary Objective: ‐ To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin after 52 weeks of treatment; ‐ To show that dapagliflozin plus metformin treatment leads to fewer patients with hypoglycaemic events compared to glipizide plus metformin after 52 weeks of treatment; ‐ To show that a higher percentage of patients treated with dapagliflozin plus metformin reduce their baseline body weight with at least 5% compared to patients treated with glipizide plus metformin after 52 weeks of treatment. INCLUSION CRITERIA: Provision of a written informed consent Diagnosed with type 2 diabetes Men or women equal or above 18 years WOCBP must be using an adequate method of contraception Treated with OAD therapy that includes metformin for at least 8 weeks prior to enrolment HbA1c above 6.5% and equal or below 10.0% FPG equal or below 270 mg/dL C‐peptid level equal or above 1.0 ng/mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range