Status:
COMPLETED
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
- HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
- HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase
- Exclusion criteria:
- Myocardial infarction, stroke or transient ischemic attack (TIA)
- Impaired hepatic function
- Renal failure or renal impairment
- Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
- Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1560 Patients enrolled
Trial Details
Trial ID
NCT00622284
Start Date
February 1 2008
Last Update
January 29 2014
Active Locations (221)
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1
1218.20.10033 Boehringer Ingelheim Investigational Site
Tempe, Arizona, United States
2
1218.20.10003 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
3
1218.20.10020 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
4
1218.20.10035 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States