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

Completed · Phase 1

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00388986

Run by

Hoffmann-La Roche

People needed

18

Starts

2006-10-01

Expected to finish

2007-07-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Cypress, California, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Buffalo, New York, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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