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

NCT ID: NCT00388986

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

100mg po bid

Glyburide

Intervention Type DRUG

10-20mg po daily

2

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

100mg po bid

3

Group Type EXPERIMENTAL

Glyburide

Intervention Type DRUG

10-20mg po daily

Interventions

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GK Activator (2)

100mg po bid

Intervention Type DRUG

Glyburide

10-20mg po daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Cypress, California, United States

Site Status

Honolulu, Hawaii, United States

Site Status

Buffalo, New York, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NP20194

Identifier Type: -

Identifier Source: org_study_id