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

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ClinicalTrials.gov Identifier: NCT00377442
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: GK Activator (2) Drug: Simvastatin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Simvastatin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. AUC0-inf of GK Activator (2) and simvastatin acid. [ Time Frame: Days 1, 8 and 15 ]
  2. AUC0-6h of plasma glucose from pre-dose to 6h post-dose. [ Time Frame: Days 1, 8 and 15 ]

Secondary Outcome Measures :
  1. AUC0-6h of GK Activator (2) and simvastatin acid [ Time Frame: Days 1, 8 and 15 ]
  2. AUC0-inf of M4 and simvastatin; CL/F, Cmax, tmax, t1/2. [ Time Frame: Days 1, 8 and 15 ]
  3. Cmin, tmin, Cmax, tmax, plasma glucose. [ Time Frame: Days 1, 8 and 15 ]
  4. AEs, laboratory parameters. [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377442


Locations
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United States, Texas
San Antonio, Texas, United States, 78229
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377442    
Other Study ID Numbers: NP20413
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors