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

Completed · Phase 1

Conditions studied: Glucose Lowering

In brief

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.

Key facts

Study ID

NCT01069926

Run by

AstraZeneca

People needed

21

Starts

2010-03-01

Expected to finish

2010-10-01

Last updated by the study team

2010-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Orlando, Florida, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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