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

Phase 1

Completed

• Conditions: Glucose Lowering

• Registration Number: NCT01069926
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Study Start: 2010-03
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change-from-baseline variables will be calculated for the safety variables listed below, as the post-treatment value minus the value at baseline	The baseline values will be as follows:

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety of AZD1656 in T2DM patients with various degrees of renal impairment. To describe the pharmacodynamics of AZD1656 in T2DM patients with various degrees of renal impairment by assessment of 24-hours glucose profile	blood samples will be collected for up to 48 hours postdose and urine samples for up to 12 hours postdose for measurement of plasma and urine concentrations of AZD1656 and its metabolite

Trial Locations

Locations (1)

Research Site; 🇺🇸 Knoxville, Tennessee, United States