A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00388986

Enrollment

Registered

2006-10-17

Start date

2006-10-31

Completion date

2007-07-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

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.

Interventions

DRUGGK Activator (2)

100mg po bid

DRUGGlyburide

10-20mg po daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
AUC0-6h of plasma glucose	Days -1, 6 and 12
AUC0-12h of GK Activator (2) and metabolite.	Days 6 and 12
AUC0-tau of glyburide	Days -1 and 6

Secondary

Measure	Time frame
AEs, laboratory parameters.	Throughout study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026