A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/3/2016 |
| Start Date: | October 2006 |
| End Date: | July 2007 |
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.
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.
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.
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.
We found this trial at
4
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials