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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00388986

Purpose

This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. 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: Glyburide	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	An Open-Label, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction Between Glyburide and GK Activator(2) in Type 2 Diabetes Patients Inadequately Controlled With Glyburide as Standard Prescribed Therapy.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glyburide

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AUC0-6h of plasma glucose [ Time Frame: Days -1, 6 and 12 ] [ Designated as safety issue: No ]
AUC0-12h of GK Activator (2) and metabolite. [ Time Frame: Days 6 and 12 ] [ Designated as safety issue: No ]
AUC0-tau of glyburide [ Time Frame: Days -1 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	18
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: GK Activator (2) 100mg po bid Drug: Glyburide 10-20mg po daily
2: Experimental	Drug: GK Activator (2) 100mg po bid
3: Experimental	Drug: Glyburide 10-20mg po daily

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; currently on glyburide 10-20 mg/day for >=3 months;
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 with 6 weeks of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388986

Locations

United States, California

CYPRESS, California, United States, 90630
United States, Hawaii

HONOLULU, Hawaii, United States, 96813
United States, New York

BUFFALO, New York, United States, NY 14215
United States, Texas

SAN ANTONIO, Texas, United States, 78229

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:	NP20194
Study First Received:	October 16, 2006
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00388986 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glyburide
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009