Status:
COMPLETED
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00800683
Start Date
December 1 2008
Last Update
May 20 2014
Active Locations (53)
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1
1218.43.10027 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
2
1218.43.10011 Boehringer Ingelheim Investigational Site
Chula Vista, California, United States
3
1218.43.10006 Boehringer Ingelheim Investigational Site
Riverside, California, United States
4
1218.43.10021 Boehringer Ingelheim Investigational Site
Whittier, California, United States