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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377442
First Posted: September 18, 2006
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
September 15, 2006
September 18, 2006
November 2, 2016
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 ]
  • AUC0-6h of plasma glucose from pre-dose to 6h post-dose. [ Time Frame: Days 1, 8 and 15 ]
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 ]
  • AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. [ Time Frame: Days 1, 8 and 15 ]
  • Cmin, tmin, Cmax, tmax, plasma glucose. [ Time Frame: Days 1, 8 and 15 ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ]
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 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00377442
NP20413
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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