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

NCT ID: NCT01069926

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Glucose Lowering

Keywords

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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AZD1656

Single dose oral tablet

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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William Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Medical Center

Locations

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Research Site

Orlando, Florida, United States

Site Status

Research Site

Overland Park, Kansas, United States

Site Status

Research Site

Minneapolis, Minnesota, United States

Site Status

Research Site

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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D1020C00007

Identifier Type: -

Identifier Source: org_study_id