Status:
COMPLETED
Comprehensive Add on Study in Japan
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insuff...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosis of type 2 diabetes mellitus
- Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug
- Exclusion criteria:
- Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
- Impaired hepatic function
- Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate \<30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate \<60 ml/min (moderate renal impairment) at Visit 1
- Treatment with anti-obesity drugs
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
574 Patients enrolled
Trial Details
Trial ID
NCT01204294
Start Date
September 1 2010
End Date
January 1 2012
Last Update
March 28 2014
Active Locations (43)
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1
1218.78.008 Boehringer Ingelheim Investigational Site
Akishima, Tokyo, Japan
2
1218.78.030 Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo, Japan
3
1218.78.017 Boehringer Ingelheim Investigational Site
Annaka, Gunma, Japan
4
1218.78.006 Boehringer Ingelheim Investigational Site
Aomori, Aomori, Japan