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: October 6, 2014
Last verified: October 2014
  Purpose

This study will assess the potential pharmacodynamic and potential pharmacokinet ic interaction between GK Activator (2) and glyburide, in type 2 diabetes patien ts not adequately controlled with glyburide as standard prescribed therapy. Pati ents will enter the study taking a dose of glyburide (10-20mg po daily) as presc ribed 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. Th e anticipated time on study treatment is <3 months, and the target sample size i s <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:


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
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

No publications provided

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: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glyburide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014