A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | January 2006 |
| End Date: | August 2007 |
An Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics/Pharmacodynamics and Safety of GK Activator (2) Following a Single Oral Dose Administration in Patients With Type 2 Diabetes.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- type 1 diabetes;
- treatment with insulin or PPAR gamma agonist within 6 months of screening.
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