Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

to determine safety, efficacy and tolerability of BI 1356 versus placebo

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Linagliptin

Criteria

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