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: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: GK Activator (2)
Drug: Simvastatin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: August 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: GK Activator (2)
100mg po
Experimental: 2 Drug: Simvastatin
80mg po
Experimental: 3 Drug: GK Activator (2)
100mg po
Drug: Simvastatin
80mg po

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377442

Locations
United States, Texas
San Antonio, Texas, United States, 78229
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377442     History of Changes
Other Study ID Numbers: NP20413
Study First Received: September 15, 2006
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014