Status:
COMPLETED
Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female patients with type 2 diabetes and insufficient glycaemic control.
- Age 18 or over and not older than 80 years
- Exclusion criteria:
- Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
- Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
503 Patients enrolled
Trial Details
Trial ID
NCT00621140
Start Date
February 1 2008
Last Update
February 17 2014
Active Locations (69)
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1
1218.16.38605 Boehringer Ingelheim Investigational Site
Krapinske Toplice, Croatia
2
1218.16.38604 Boehringer Ingelheim Investigational Site
Slavonski Brod, Croatia
3
1218.16.91009 Boehringer Ingelheim Investigational Site
Andhra Pradesh, India
4
1218.16.91002 Boehringer Ingelheim Investigational Site
Bangalore, India