Status:
COMPLETED
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previou...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm
- Exclusion criteria:
- Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
857 Patients enrolled
Trial Details
Trial ID
NCT00798161
Start Date
December 1 2008
Last Update
January 28 2014
Active Locations (138)
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1
1218.46.11005 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
2
1218.46.11003 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
3
1218.46.11002 Boehringer Ingelheim Investigational Site
Red Deer, Alberta, Canada
4
1218.46.11006 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada