Status:
COMPLETED
Randomized, Double-blind (db), Placebo-controlled 18 Week Study of Linagliptin (BI 1356) in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control \[glycosylated hemoglobin (HbA1c 7% to 10%)\] despite therapy with a sulfonylurea drug
- Exclusion criteria:
- Myocardial infarction,stroke or transient ischaemic attack in last 6 months Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in the past 3 months Impaired hepatic function Severe renal impairment Current treatment with systemic steroids Change in thyroid hormone dosage Hereditary galactose intolerance
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00819091
Start Date
December 1 2008
Last Update
June 27 2014
Active Locations (45)
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1
1218.35.10002 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
1218.35.10001 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
3
1218.35.10016 Boehringer Ingelheim Investigational Site
National City, California, United States
4
1218.35.10017 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States