A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:August 2006
End Date:April 2007

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Open-label Crossover Study to Investigate the Potential Interaction Between GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes

This study will assess the potential pharmacokinetic interaction between GK Activator (2)
and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of
GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6
treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin
80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study
days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The
anticipated time on study treatment is <3 months, and the target sample size is <100
individuals.


Inclusion Criteria:

- adult patients aged 18-75 years;

- type 2 diabetes mellitus;

- untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start.

Exclusion Criteria:

- type 1 diabetes mellitus, or latent autoimmune diabetes in adults;

- diabetic neuropathy, retinopathy or nephropathy;

- patients treated with insulin or PPAR gamma agonist within 6 weeks of screening.
We found this trial at
2
sites
Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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San Antonio, TX
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Clinical Trial Facility in Tacoma Washington
Tacoma, Washington
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Tacoma, WA
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