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

Completed · Phase 1

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00377442

Run by

Hoffmann-La Roche

People needed

33

Starts

2006-08-01

Expected to finish

2007-04-01

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 aged 18-75 years;
• type 2 diabetes mellitus;
• untreated, or taken off anti-diabetic or statin therapy >=2 weeks before study start.

You may not qualify if…

• 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.

Where it is running

• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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