A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 (25 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin therapy

INTERVENTION: Product Name: BI 10773 Product Code: BI 10773 Pharmaceutical Form: Film‐coated tablet Current Sponsor code: BI 10773 Other descriptive name: BI 10773 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Amaryl Product Name: Amaryl Pharmaceutical Form: Tablet INN or Proposed INN: GLIMEPIRIDE CAS Number: 93479971 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Amaryl Product Name: Amaryl Pharmaceutical Form: Tablet INN or Proposed INN: GLIMEPIRIDE CAS Number: 93479971 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Amaryl Product Name: Amaryl Pharmaceutical Form: Tablet INN or Proposed INN: GLIMEPIRIDE CAS Number: 93479971 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Amaryl Product Name: Amaryl Pharmaceutical Form: Tablet INN or Proposed INN: GLIMEPIRIDE CAS Number: 93479971 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Type 2 diabetes mellitus pre‐treated with metformin ; MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus PRIMARY OUTCOME: Main Objective: The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1‐4mg daily) given for 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin. Primary end point(s): The change from baseline in HbA1c after 52 weeks and 104 weeks. Secondary Objective: Key secondary endpoints:; 1) Change in body weight from baseline after 52 weeks and 104 weeks of treatment.; 2) The occurence of confirmed symptomatic hypoglycemic events during 52 weeks and 104 weeks.; 3) Change in blood pressure ( SBP and DBP) from baseline after 52 weeks and 104 weeks. INCLUSION CRITERIA: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are pre‐treated with a stable maximum tolerated dose of metformin unchanged for 12 weeks prior to randomisation. (Preferably >/= 1500mg/day metformin) 3. HbA1c of more than or equal to 7.0% and less or equal to 10.0% at Visit 1 (screening) 4. Age more than or equal to 18yrs 5. BMI more or than or equal to 45 kg/m2 (Body Mass Index) at Visit 1 (Screening) 6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation 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