Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of the study is to evaluate the absorption, distribution, metabolism and excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656 solution in male Type 2 Diabetes Mellitus patients.

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Detailed Description

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Conditions

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Type II Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

14C-labelled AZD1656

Group Type EXPERIMENTAL

AZD1656

Intervention Type DEVICE

Oral single dose

Interventions

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AZD1656

Oral single dose

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male type II diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years.
* Subjects treated with metformin alone or metformin and one other oral anti-diabetic drug.
* Subjects should have FPG in the range of 6.0 to 11.0 mmol/L at screening and HbA1c less than 10% (HbA1c value according to international DCCT standard).

Exclusion Criteria

* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
* Renal dysfunction.
* Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of IP.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No