Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
- NCT00800683
- PHASE3
- INTERVENTIONAL
Last updated: 2014-05-20
Purpose of Trial
to determine safety, efficacy and tolerability of BI 1356 versus placebo
This study is for people with
Diabetes Mellitus, Type 2
Interventions being studied
BI 1356
placebo
Inclusion criteria:
* Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) \<30 ml/min, who are not on chronic dialysis.
* Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
* Age 18 or over and not older than 80 years
Exclusion criteria:
* Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
* Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
* Unstable or acute congestive heart failure
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
24 Locations
Phoenix
1218.43.10027 Boehringer Ingelheim Investigational Site
Arizona, United States
Chula Vista
1218.43.10011 Boehringer Ingelheim Investigational Site
California, United States
Riverside
1218.43.10006 Boehringer Ingelheim Investigational Site
California, United States
Whittier
1218.43.10021 Boehringer Ingelheim Investigational Site
California, United States
Pembroke Pines
1218.43.10013 Boehringer Ingelheim Investigational Site
Florida, United States
West Palm Beach
1218.43.10009 Boehringer Ingelheim Investigational Site
Florida, United States
Decatur
1218.43.10018 Boehringer Ingelheim Investigational Site
Georgia, United States
Chicago
1218.43.10022 Boehringer Ingelheim Investigational Site
Illinois, United States
Shreveport
1218.43.10015 Boehringer Ingelheim Investigational Site
Louisiana, United States
Kansas City
1218.43.10016 Boehringer Ingelheim Investigational Site
Missouri, United States
Bronx
1218.43.10004 Boehringer Ingelheim Investigational Site
New York, United States
Great Neck
1218.43.10003 Boehringer Ingelheim Investigational Site
New York, United States
Winston-Salem
1218.43.10020 Boehringer Ingelheim Investigational Site
North Carolina, United States
Delaware
1218.43.10019 Boehringer Ingelheim Investigational Site
Ohio, United States
Mentor
1218.43.10008 Boehringer Ingelheim Investigational Site
Ohio, United States
Bethlehem
1218.43.10005 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Carlisle
1218.43.10007 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Providence
1218.43.10001 Boehringer Ingelheim Investigational Site
Rhode Island, United States
Aiken
1218.43.10025 Boehringer Ingelheim Investigational Site
South Carolina, United States
Austin
1218.43.10023 Boehringer Ingelheim Investigational Site
Texas, United States
Austin
1218.43.10024 Boehringer Ingelheim Investigational Site
Texas, United States
Dallas
1218.43.10014 Boehringer Ingelheim Investigational Site
Texas, United States
Lufkin
1218.43.10017 Boehringer Ingelheim Investigational Site
Texas, United States
Tacoma
1218.43.10010 Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov