A 4-week, randomized, double blind, double dummy, placebo controlled, parallel group study comparing the influence of BI 1356 (5 mg) and sitagliptin (100 mg) administered orally once daily on various biomarkers in type 2 diabetic patients

INTERVENTION: Product Name: BI 1356 Product Code: BI 1356 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: linagliptin Current Sponsor code: BI 1356 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Januvia Pharmaceutical Form: Capsule, hard INN or Proposed INN: sitagliptin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ 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: The objective of the current study is to compare the effect of BI 1356 (5 mg) and sitagliptin (100 mg) on 24‐h glucose control with placebo and with each other in type 2 diabetic patients with inadequate glycaemic control. In addition, various pharmacodynamic parameters (e.g. GLP‐1, insulin, DPP‐4 inhibition) will be investigated. All treatments will be given once daily over four weeks. Primary end point(s): The primary endpoint of the study is the change from baseline in weighted mean glucose (WMG) to day 28. Weighted mean glucose will be determined by calculating the area under the glucose concentration time curve over a time interval of 24 h (by linear trapezoidal algorithm) divided by 24 h. ; In addition, the change from baseline for GLP‐1 AUEC0‐2h following an MTT on day 28 will be investigated as a primary endpoint.; Secondary Objective: INCLUSION CRITERIA: 1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug; the antidiabetic therapy has to be unchanged for 12 weeks prior to informed consent. 2. Diagnosis of type 2 diabetes prior to informed consent 3. Glycosylated haemoglobin A1 (HbA1c) at visit 1a (Screening) For patients undergoing wash‐out of previous medication: HbA1c =6.5 to =9.0% For patients not undergoing wash‐out of previous medication: HbA1c =6.5 to =10.0% 4. Glycosylated haemoglobin A1 (HbA1c) =6.5 to =10.0% at visit 2 (Start of Run in) 5. Age =18 and = 80 years at visit 1a (Screening) 6. BMI = 40 kg/m2 (Body Mass Index) at visit 1a (Screening) 7. Signed and dated written informed consent by date of visit 1a 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