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A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT00266240

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

PHASE2

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-05-31

Brief Summary

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This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

Escalating doses po bid

2

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

Escalating doses po bid

3

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

Escalating doses po bid

4

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

Escalating doses po bid

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po bid

Interventions

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GK Activator (2)

Escalating doses po bid

Intervention Type DRUG

Placebo

po bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients 30-75 years of age;
* type 2 diabetes mellitus for \>3 months before screening;
* treatment-naive, inadequately controlled diabetes despite diet and exercise, or inadequately controlled diabetes in patients on monotherapy or combination therapy (maximum of 2 oral anti-hyperglycemic medications).

Exclusion Criteria

* type 1 diabetes mellitus;
* women who are pregnant, breast-feeding or not using adequate contraceptive methods.
Minimum Eligible Age

30 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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Tucson, Arizona, United States

Site Status

Pine Bluff, Arkansas, United States

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Chula Vista, California, United States

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Spring Valley, California, United States

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West Hills, California, United States

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Hollywood, Florida, United States

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Atlanta, Georgia, United States

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Binghamton, New York, United States

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Fayetteville, North Carolina, United States

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Statesville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Springdale, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Beaver, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Plano, Texas, United States

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Renton, Washington, United States

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Dimitrovgrad, , Bulgaria

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Pleven, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Zagreb, , Croatia

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Guatemala City, , Guatemala

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Budapest, , Hungary

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Budapest, , Hungary

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Győr, , Hungary

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Kecskemét, , Hungary

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Chihuahua City, , Mexico

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Cuernavaca, , Mexico

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Durango, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Bialystok, , Poland

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Gdansk, , Poland

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Gorzów, , Poland

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Krakow, , Poland

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Wroclaw, , Poland

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Countries

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United States Bulgaria Croatia Guatemala Hungary Mexico Poland

Other Identifiers

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BM18248

Identifier Type: -

Identifier Source: org_study_id