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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: BI 1356

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800683

1218.43

2008-001569-27 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 133 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 2 patient groups, including a placebo group

BI 1356

Experimental group

Description:

patient to receive a tablet containing BI 1356 once daily

Treatment:

Drug: BI 1356

placebo

Placebo Comparator group

Description:

patient to receive a tablet identical to BI 1356 once daily

Treatment:

Drug: placebo