Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Finland Ky
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 metformin alone, or with metformin and not more than one other oral antidiabetic drug (antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent and patients should receive standard diet and exercise counseling) 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 =7.0 to =10.0% 4.Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in) 5.Age =18 and = 80 years at Visit 1a (Screening) 6.BMI (Body Mass Index) = 40 kg/m2 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 or its excipients or metformin or placebo 4.Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent 5.Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent 6.Treatment with insulin within 3 months prior to informed consent 7.Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent 8.Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse 9.Participation in another trial with an investigational drug within 2 months prior to informed consent 10.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, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made. 11.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 12.Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a) 13.Dehydration by clinical judgement of the investigator 14.Unstable or acute congestive heart failure 15.Acute or chronic metabolic acidosis (present in patient history) 16.Hereditary galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. ;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 24 weeks of treatment). Throughout the study protocol, the term "baseline" refers to the last observation prior to the randomised period.;Secondary Objective: Secondary endpoints are •The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of <7.0% after 24 weeks of treatment •Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) •HbA1c reduction from baseline by visit over time •The change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment •The change from baseline in fasting plasma glucose (FPG) by visit over time •Meal Tolerance Test (MTT): two-hour postprandial glucose (2hPPG) at baseline, after 24 weeks of treatment and change from baseline to week 24 •The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <6.5% after 24 weeks of treatment | — |
Countries
Czech Republic, Finland, Greece, Sweden
Outcome results
None listed