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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377442
First received: September 15, 2006
Last updated: October 6, 2014
Last verified: October 2014

September 15, 2006
October 6, 2014
August 2006
April 2007   (final data collection date for primary outcome measure)
  • AUC0-inf of GK Activator (2) and simvastatin acid. [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]
  • AUC0-6h of plasma glucose from pre-dose to 6h post-dose. [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]
Pk: AUC0-inf of GK Activator (2) and simvastatin acid. Pd: AUC0-6h of plasma glucose from pre-dose to 6h post-dose.
Complete list of historical versions of study NCT00377442 on ClinicalTrials.gov Archive Site
  • AUC0-6h of GK Activator (2) and simvastatin acid [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]
  • AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]
  • Cmin, tmin, Cmax, tmax, plasma glucose. [ Time Frame: Days 1, 8 and 15 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Pk: AUC0-6h of GK Activator (2) and simvastatin acid; AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. Pd: Cmin, tmin, Cmax, tmax, plasma glucose. Safety: AEs, laboratory parameters.
Not Provided
Not Provided
 
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
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 Acti vator (2) and simvastatin, and the potential effect of simvastatin on the glucos e-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 ther e 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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: GK Activator (2)
    100mg po
  • Drug: Simvastatin
    80mg po
  • Experimental: 1
    Intervention: Drug: GK Activator (2)
  • Experimental: 2
    Intervention: Drug: Simvastatin
  • Experimental: 3
    Interventions:
    • Drug: GK Activator (2)
    • Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
April 2007
April 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00377442
NP20413
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP