Randomized, db, Placebo-Controlled 18 Week Study of BI 1356 in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Phase 3
Completed
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Registration Number
- CTRI/2009/091/000119
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 255
Inclusion Criteria
Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) despite therapy with a sulfonylurea drug
Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Exclusion Criteria
Myocardial infarction,stroke or transient ischaemic attack in last 6 months - Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months - Impaired hepatic function - Severe renal impairment - Current treatment with systemic steroids - Change in thyroid hormone dosage - Hereditary galactose intolerance
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is change from baseline HbA1c after 18 weeks of treatment.Timepoint: After 18 weeks of treatment
- Secondary Outcome Measures
Name Time Method HbA1c <7.0%Timepoint: After 18 weeks of treatment