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
Completed · Phase 3 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT00819091
- Run by
- Boehringer Ingelheim
- People needed
- 245
- Starts
- 2008-12-01
- Last updated by the study team
- 2014-06-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 1218.35.10002 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
- 1218.35.10001 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
- 1218.35.10016 Boehringer Ingelheim Investigational Site — National City, California, United States
- 1218.35.10017 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
- 1218.35.10021 Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
- 1218.35.10013 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
- 1218.35.10015 Boehringer Ingelheim Investigational Site — Flint, Michigan, United States
- 1218.35.10018 Boehringer Ingelheim Investigational Site — Asheville, North Carolina, United States
- 1218.35.10004 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
- 1218.35.10005 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
- 1218.35.10020 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
- 1218.35.10009 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
- 1218.35.10019 Boehringer Ingelheim Investigational Site — Sugar Land, Texas, United States
- 1218.35.54003 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
- 1218.35.54005 Boehringer Ingelheim Investigational Site — Corrientes, Argentina
- 1218.35.54001 Boehringer Ingelheim Investigational Site — Mar del Plata, Argentina
- 1218.35.54006 Boehringer Ingelheim Investigational Site — Parque Velez Sarfield, Argentina
- 1218.35.36001 Boehringer Ingelheim Investigational Site — Budapest, Hungary
- 1218.35.36002 Boehringer Ingelheim Investigational Site — Budapest, Hungary
- 1218.35.36004 Boehringer Ingelheim Investigational Site — Budapest, Hungary
- 1218.35.36005 Boehringer Ingelheim Investigational Site — Budapest, Hungary
- 1218.35.36003 Boehringer Ingelheim Investigational Site — Debrecen, Hungary
- 1218.35.91003 Boehringer Ingelheim Investigational Site — Aligarh, Uttar Pradesh, India
- 1218.35.91007 Boehringer Ingelheim Investigational Site — Aminjikarai, Tamilnadu, India
- 1218.35.91001 Boehringer Ingelheim Investigational Site — Bangalore, Karnataka, India
Full record on ClinicalTrials.gov
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