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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01069926
• Collaborator: (none)
• Enrollment: 21
• Locations: 4
• Duration (Months): 7
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Lowering	Drug: AZD1656	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: A Phase I, Multi-center, Open-label, Single Dose Study, to Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients With or Without Renal Impairment
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Outcome Measures

Primary Outcome Measures

1. 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

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Orlando	Florida	United States
2	Research Site	Overland Park	Kansas	United States
3	Research Site	Minneapolis	Minnesota	United States
4	Research Site	Knoxville	Tennessee	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: William Smith, MD, University of Tennessee Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01069926
• Other Study ID Numbers: D1020C00007
• First Posted: Feb 17, 2010
• Last Update Posted: Dec 9, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Diabetes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 9, 2010