Status:
COMPLETED
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00377442
Start Date
August 1 2006
End Date
April 1 2007
Last Update
November 2 2016
Active Locations (2)
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1
San Antonio, Texas, United States, 78229
2
Tacoma, Washington, United States, 98418