Overview

To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
Summary
To assess the pharmacokinetics of AZD1656, and its metabolite, in type 2 diabetes mellitus patients with varying degrees of renal impairment and to compare the results with those in patients with normal renal function.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:

- Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any OAD
or insulin

- Calculated MDRD GFR based on S-creatinine at enrollment should fall within any of the
4 categories: mild , moderate, severe normal

Exclusion Criteria:

- Clinically significant progression of current disease or clinically relevant trauma,
as judged by the Investigator, within 2 weeks before the first administration of the
IP

- Clinically significant neuropathy according to the Investigator. However subjects with
diabetic neuropathy which is not clinically significant according to the Investigator
may be included.