A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated (6 weeks washout) type 2 diabetic patients with insufficient glycaemic control
Phase 1
- Conditions
- Diabetes mellitus type 2MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2007-002448-10-SK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Signed and dated informed consent
Type 2 diabetes mellitus, treated with a maximum of 1 antidiabetic drug.
HbA1c >=6.5 and =<9% at start of wash-out of current medication and >=7%, =<10% after wash-out
BMI =<40
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
Myocardial infarction, stoke or TIA wihtin 6 months prior to consent
Impaired hepatic function
Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to consent
Treatment with more than 1 antidiabetic drug within 10 weeks prior to consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate efficacy, safety and tollerability of BI 1356 in patients with type 2 diabetes mellitus and insufficient glycaemic control;Secondary Objective: ;Primary end point(s): Change from baseline in HbA1c
- Secondary Outcome Measures
Name Time Method