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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Glucose Lowering

Treatments: Drug: AZD1656

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069926

D1020C00007

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.