Type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10029505 Term: Non-insulin-dependent diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: 1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent 2. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at visit 1a 3. Known hypersensitivity or allergy to the investigational product, sitagliptin or the excipients 4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent 5. Treatment with GLP-1 analogues within 3 months prior to informed consent 6. Treatment with insulin within 3 months prior to informed consent 7. Treatment with DPP-4 inhibitors 3 months prior to informed consent 8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent 9. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation. Drug abuse. 10. Participation in another trial with an investigational drug within 2 months prior to informed consent 11. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, hormonal intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made. 12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 13. Renal insufficiency with a creatinine clearance < 50 mL/min as determined at visit 1a 14. Blood donation (more than 100 mL) within four weeks prior to first study-drug administration or during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: ;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. | — |
Countries
Germany
Outcome results
None listed