A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
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ClinicalTrials.gov Identifier: NCT00388986 |
Recruitment Status :
Completed
First Posted : October 17, 2006
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Type 2 | Drug: GK Activator (2) Drug: Glyburide | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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. |
Study Start Date : | October 2006 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
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 |
- AUC0-6h of plasma glucose [ Time Frame: Days -1, 6 and 12 ]
- AUC0-12h of GK Activator (2) and metabolite. [ Time Frame: Days 6 and 12 ]
- AUC0-tau of glyburide [ Time Frame: Days -1 and 6 ]
- AEs, laboratory parameters. [ Time Frame: Throughout study ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388986
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 |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00388986 |
Other Study ID Numbers: |
NP20194 |
First Posted: | October 17, 2006 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Glyburide Hypoglycemic Agents Physiological Effects of Drugs |