A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.

Completed · Phase 1

Conditions studied: Diabetes Mellitus Type 2

In brief

This study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of GK Activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. Patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). After a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg GK Activator (2), and blood and urine samples will be taken up to 96h post-dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Key facts

Study ID

NCT00368368

Run by

Hoffmann-La Roche

People needed

5

Starts

2006-01-01

Expected to finish

2007-08-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-75 years of age;
• type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for >=1 week prior to dosing with GK Activator (2);
• normal renal function, or moderate or severe impairment.

You may not qualify if…

• type 1 diabetes;
• treatment with insulin or PPAR gamma agonist within 6 months of screening.

Where it is running

• Study site — Cypress, California, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Bratislava, Slovakia

Full record on ClinicalTrials.gov

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