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

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Glyburide; Drug: GK Activator (2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00388986

NP20194

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: GK Activator (2)

Drug: Glyburide

2

Experimental group

Treatment:

Drug: GK Activator (2)

3

Experimental group

Treatment:

Drug: Glyburide