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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00377442

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Simvastatin

U.S. FDA Resources

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 Completion Date:	April 2007

Arms	Assigned Interventions
1: Experimental	Drug: GK Activator (2) 100mg po
2: Experimental	Drug: Simvastatin 80mg po
3: Experimental	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, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NP20413
Study First Received:	September 15, 2006
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00377442 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010