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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: GK Activator (2); Drug: Simvastatin

• Registration Number: NCT00377442
• Lead Sponsor: Hoffmann-La Roche

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-15
• Study First Submitted QC: 2006-09-15
• Study First Posted: 2006-09-18
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	GK Activator (2)	-
2	Simvastatin	-
3	GK Activator (2)	-
3	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
AUC0-inf of GK Activator (2) and simvastatin acid.	Days 1, 8 and 15
AUC0-6h of plasma glucose from pre-dose to 6h post-dose.	Days 1, 8 and 15

Secondary Outcome Measures

Name	Time	Method
AUC0-6h of GK Activator (2) and simvastatin acid	Days 1, 8 and 15
AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2.	Days 1, 8 and 15
Cmin, tmin, Cmax, tmax, plasma glucose.	Days 1, 8 and 15
AEs, laboratory parameters.	Throughout study