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.

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

sites

Clinical Trial Facility in Honolulu Hawaii

Honolulu, Hawaii

from

Honolulu, HI