A randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 1356 (5.0 mg, administered orally once daily) compared to glimepiride (1 to 4 mg once daily) over two years, in type 2 diabetic patients with insufficient glycaemic control despite metformin therapy - ND
- Conditions
- patients with type 2 diabetes mellitus with insufficient glycaemic control.MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2007-004585-40-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2400
-Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin monotherapy, or with metformin plus not more than one other oral antidiabetic drug (all antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent Please note: Type 2 diabetes mellitus patients should be on a stable daily dose of preferably >= 1500 mg of metformin. Patients treated with less than 1500 mg metformin per day will only be included, if the investigator considers them on their maximum tolerated dose of metformin The metformin dose should not be increased or decreased during the trial. -Diagnosis of type 2 diabetes prior to informed consent -Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening): For patients undergoing wash-out of previous medication: HbA1c 6.0 ? 9.0% For patients not undergoing wash-out of previous medication: HbA1c 6.5 ? 10% -Glycosylated haemoglobin A1 (HbA1c) 6.5 ? 10.0% at Visit 2 (Start of Run-in) -Age >= 18 and < 80 years at Visit 1a (Screening) -Body Mass Index (BMI) ≤ 40 kg/m2 at Visit 1a (Screening) -Signed and dated written informed consent at the latest by the 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
-Myocardial infarction, stroke or TIA within 6 months prior to informed consent -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 before randomisation -Known hypersensitivity or allergy to the investigational product or its excipients, metformin or Sulfonyureas (glimepiride) -Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent -Treatment with insulin or injectable GLP-1 analogue/agonists within 3 months prior to informed consent -Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent -Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent). -Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation -Drug abuse -Participation in another trial with an investigational drug within 2 months prior to informed consent -Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who: 1. are nursing or pregnant, 2. 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 inthe 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. -Renal failure or renal impairment ( serum creatinine >1.5 mg/dl as determined before randomisation) -Hereditary galactose intolerance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method