A phase IIb, randomised, double-blind, placebo-controlled, parallel group, safety and efficacy study of BI 10773 (10 mg and 25 mg) administered orally, over 78 weeks in type 2 diabetic patients receiving treatment with basal insulin (glargine, detemir, or NPH insulin only) with or without concomitant metformin and/or sulfonylurea therapy and insufficient glycaemic control

INTERVENTION: Product Name: BI 10773 Product Code: BI 10773 Pharmaceutical Form: Tablet Current Sponsor code: BI 10773 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: BI 10773 Product Code: BI 10773 Pharmaceutical Form: Tablet Current Sponsor code: BI 10773 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] Type 2 Diabetes Mellitus ; MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 ‐ Metabolism and nutrition disorders PRIMARY OUTCOME: Main Objective: The primary endpoint in this study is the change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the observation at the randomization visit (Visit 3) prior to treatment. Primary end point(s): The primary endpoint in this study is the change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the observation at the randomization visit (Visit 3) prior to treatment. Secondary Objective: Key secondary endpoints:; • Change from baseline in dose of basal insulin dose after 78 weeks of treatment; • Change from baseline in HbA1c after 78 weeks of treatment; ; Secondary endpoints; • The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% after 18, 54 and 78 weeks of treatment; • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 18, 54 and 78 weeks of treatment; • Change from baseline in HbA1c after 54 weeks of treatment; • Change from baseline in dose of basal insulin dose after 54 weeks of treatment; • The change from baseline and percent change from baseline in fasting plasma glucose (FPG) after 18, 54, and 78 weeks of treatment INCLUSION CRITERIA: • Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation • Male and female patients with a diagnosis of T2DM treated with basal glargine or detemir insulin (=20 IU/day) or NPH insulin (=14 IU/day) with or without concomitant metformin and / or sulfonylurea. The total insulin dose should not be changed by more than 10% of the baseline value within the 12 weeks prior to randomization. The oral anti‐diabetic therapy has to be unchanged for at least 12 weeks prior to randomization. • HbA1c of >7.0% and =10% at Visit 1 (screening) • Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study) • Age =18 years at Visit 1 (screening) • BMI =45 kg/m2 (Body Mass Index) at Visit 1 (screening) Are the trial subjects under 18? no Number of subjects for this