A randomised, double-blind, placebo-controlled, five parallel groups study investigating the efficacy and safety of BI 1356 BS (1mg, 5mg and 10mg administered orally once daily) over 12 weeks as add-on therapy in patients with type 2 diabetes and insufficient glycaemic control despite metformin therapy, including an open-label glimepiride treatment arm.
- Conditions
- Patients with type 2 diabetesMedDRA version: 8.1Level: PTClassification code 10012613
- Registration Number
- EUCTR2005-004597-24-SK
- Lead Sponsor
- Boehringer Ingelheim Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 375
1.) Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug other than rosiglitazone or pioglitazone (antidiabetic therapy has to be unchanged for 10 weeks prior to screening)
2.) Diagnosis of type 2 diabetes with a duration of at least 3 months
3.) Glycosylated haemoglobin A1 (HbA1c) 7.0 – 9.0 % at screening for patients treated with metformin and one other oral antidiabetic drug
Glycosylated haemoglobin A1 (HbA1c) 7.5 – 10.0 % at screening for patients treated with metformin alone
4.) Glycosylated haemoglobin A1 (HbA1c) 7.5 – 10.0 % at Visit 3 (beginning of the 2-week placebo run-in phase)
5.) Age >= 21 and <= 75 years
6.) BMI >= 25 and <= 40 kg/m2 (Body Mass Index)
7.) Signed and dated written informed consent prior to admission to the study 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
1.) Clinically relevant cardiovascular disease or myocardial infarction, stroke or TIA within six month prior to enrolment
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)
3.) Renal insufficiency or impaired renal function defined by serum creatinine above ULN at screening
4.) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurological disorders (including cerebrovascular) besides polyneuropathy that would interfere with participation in the trial
5.) Chronic or clinically relevant acute infections (e.g. HIV, Hepatitis)
6.) History of clinically relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
7.) Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
8.) Treatment with insulin within 3 month prior to screening
9.) Alcohol abuse within the last 3 months that would interfere with trial participation or drug abuse
10.) Participation in another trial with an investigational drug within two months prior to administration or during this trial
11.) Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at visit 2, 3 or 4 and confirmed by second measurement (not on the same day)
12.) Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who:
a) are nursing or pregnant,
b) 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of BI 1356 BS versus placebo, efficacy of glimepiride treatment vs. placebo for sensitivity analysis, investigation of safety, population pharmacokinetics;Secondary Objective: ;Primary end point(s): The primary endpoint in this study is the change of HbA1c (HbA1c after 12 weeks of treatment minus HbA1c at baseline). Throughout the study protocol, the term baseline refers to the last observations prior to treatment phase.
- Secondary Outcome Measures
Name Time Method