A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

NCT ID: NCT00316758

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

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-10-31

Brief Summary

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This study will evaluate the long-term safety and tolerability of GK Activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. Eligible patients will be those who have completed study BM18248 (GK Activator (2) monotherapy) or BM18249 (GK Activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. The anticipated time on study treatment is 3-12 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

NONE

Study Groups

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1

Group Type EXPERIMENTAL

GK Activator (2)

Intervention Type DRUG

Escalating doses bid

Metformin

Intervention Type DRUG

As prescribed, in patients who were in study BM18249

Interventions

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GK Activator (2)

Escalating doses bid

Intervention Type DRUG

Metformin

As prescribed, in patients who were in study BM18249

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetic patients who have completed studies BM18248 or BM18249;
* patients considered by the investigator to be suitable for long term treatment with GK Activator (2).

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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Chula Vista, California, United States

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Chula Vista, California, United States

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Los Angeles, 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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Kissimmee, Florida, United States

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Atlanta, Georgia, United States

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Arkansas City, Kansas, United States

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Butte, Montana, 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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Mt. Pleasant, South Carolina, United States

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Memphis, Tennessee, United States

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Federal Way, Washington, United States

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Renton, Washington, United States

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Camperdown, , Australia

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Heidelberg, , Australia

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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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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Montreal, Quebec, Canada

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Zagreb, , Croatia

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Bammental, , Germany

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Berlin, , Germany

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Essen, , Germany

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Giessen, , Germany

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Görlitz, , Germany

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Hamburg, , Germany

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Künzing, , Germany

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Nuremberg, , Germany

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Tann, , Germany

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Guatemala City, , Guatemala

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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 Kingdom United States Australia Bulgaria Canada Croatia Germany Guatemala Hungary Mexico Poland

Other Identifiers

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NC19794

Identifier Type: -

Identifier Source: org_study_id