Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00388986 |
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. |
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
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NP20194 |
Study First Received: | October 16, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00388986 |
Health Authority: | United States: Food and Drug Administration |
Glyburide Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |