Status:
COMPLETED
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this ...
Eligibility Criteria
Inclusion
- Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)
- Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00740051
Start Date
August 1 2008
Last Update
June 27 2014
Active Locations (53)
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1
1218.50.10009 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
1218.50.10011 Boehringer Ingelheim Investigational Site
Peoria, Arizona, United States
3
1218.50.10013 Boehringer Ingelheim Investigational Site
Greenbrae, California, United States
4
1218.50.10016 Boehringer Ingelheim Investigational Site
Harbor City, California, United States