Status:
COMPLETED
Japanese P III vs Voglibose and Placebo
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose fo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
- Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
- Age: \>= 20 and \<= 80
- Body Mass Index (BMI) \<= 40 kg/m2
- Exclusion criteria:
- Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
- Impaired hepatic function
- History of severe allergy/hypersensitivity
- Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
- Fasting blood glucose \>240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT00654381
Start Date
April 1 2008
Last Update
January 27 2014
Active Locations (47)
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1
1218.23.05 Boehringer Ingelheim Investigational Site
Asahi, Chiba, Japan
2
1218.23.06 Boehringer Ingelheim Investigational Site
Funabashi, Chiba, Japan
3
1218.23.21 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki, Japan
4
1218.23.44 Boehringer Ingelheim Investigational Site
Hitachiota, Ibaraki, Japan