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

NCT ID: NCT00377442

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-04-30

Brief Summary

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This study will assess the potential pharmacokinetic interaction between GK Activator (2) and simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6 treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin 80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. 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

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

2

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

80mg po

3

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

100mg po

Simvastatin

Intervention Type DRUG

80mg po

Interventions

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GK Activator (2)

100mg po

Intervention Type DRUG

Simvastatin

80mg po

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients aged 18-75 years;
* type 2 diabetes mellitus;
* 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 within 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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San Antonio, Texas, United States

Site Status

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NP20413

Identifier Type: -

Identifier Source: org_study_id