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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00388986

First received: October 16, 2006

Last updated: September 1, 2016

Last verified: September 2016

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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 Type 2 Drug Reactions

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 Start Date:	October 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00388986 History of Changes
Other Study ID Numbers:	NP20194
Study First Received:	October 16, 2006
Last Updated:	September 1, 2016
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 Glyburide Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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