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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00316758

Public ClinicalTrials.gov record NCT00316758. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 11:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Open Label, Extension Study to Evaluate the Long-term Safety and Tolerability of GK Activator (2) in Type 2 Diabetic Patients From Studies BM18248 or BM18249

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00316758
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
259 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
30 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2006
Primary completion
Sep 30, 2007
Completion
Sep 30, 2007
Last update posted
Nov 1, 2016

2006 – 2007

United States locations

U.S. sites
22
U.S. states
14
U.S. cities
21
Facility City State ZIP Site status
Not listed Chula Vista California 91910
Not listed Chula Vista California 91911
Not listed Los Angeles California 90057
Not listed Spring Valley California 91978
Not listed West Hills California 91307
Not listed Hollywood Florida 33021
Not listed Kissimmee Florida 34741
Not listed Atlanta Georgia 30308
Not listed Arkansas City Kansas 67005
Not listed Butte Montana 59701
Not listed Binghamton New York 13901
Not listed Fayetteville North Carolina 28304
Not listed Statesville North Carolina 28625
Not listed Winston-Salem North Carolina 27103
Not listed Springdale Ohio 45246
Not listed Oklahoma City Oklahoma 73112
Not listed Medford Oregon 97504
Not listed Beaver Pennsylvania 15009
Not listed Mt. Pleasant South Carolina 29464
Not listed Memphis Tennessee 38119
Not listed Federal Way Washington 98003
Not listed Renton Washington 98055

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00316758, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 1, 2016 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00316758 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →