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

Completed · Phase 1

Conditions studied: Type II Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00960791

Run by

AstraZeneca

People needed

6

Starts

2009-07-01

Expected to finish

2009-09-01

Last updated by the study team

2009-09-16

Who can join

Age: 35 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Research Site — San Diego, California, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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