Status:
COMPLETED
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metfor...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Inclusion\_Criteria:
- Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
- HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
- HbA1c 7.5 10.0% at screening for patients treated with metformin alone
- HbA1c 7.5 10.0% at beginning of the placebo run-in phase
- Age \> 21 and \< 75 years
- MI \> 25 and \< 40 kg/m2 (Body Mass Index)
- Exclusion criteria:
- Exclusion\_Criteria:
- Clinically relevant cardiovascular disease
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
- Treatment with insulin within 3 months prior to screening
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT00309608
Start Date
April 1 2006
Last Update
July 8 2014
Active Locations (48)
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1
1218.6.3302A Boehringer Ingelheim Investigational Site
Joué Les Tours, France
2
1218.6.3303A Boehringer Ingelheim Investigational Site
Joué Les Tours, France
3
1218.6.3304A Boehringer Ingelheim Investigational Site
Joué-lès-Tours, France
4
1218.6.3305A Euraxi Pharma
Joué-lès-Tours, France