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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377442
• Other study ID #: NP20413
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2006
• Last updated: November 1, 2016
• Start date: August 2006
• Est. completion date: April 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GK Activator (2)
100mg po
• Simvastatin
80mg po

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf of GK Activator (2) and simvastatin acid.		Days 1, 8 and 15	No
Primary	AUC0-6h of plasma glucose from pre-dose to 6h post-dose.		Days 1, 8 and 15	No
Secondary	AUC0-6h of GK Activator (2) and simvastatin acid		Days 1, 8 and 15	No
Secondary	AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2.		Days 1, 8 and 15	No
Secondary	Cmin, tmin, Cmax, tmax, plasma glucose.		Days 1, 8 and 15	No
Secondary	AEs, laboratory parameters.		Throughout study	No