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Completed Phase 2 Interventional

A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

ClinicalTrials.gov ID: NCT00366379

Public ClinicalTrials.gov record NCT00366379. 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 3, 2026, 10:08 PM EDT

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

Official title

An Open Label Study to Determine the Effect on Fasting Glucose Levels, and Safety, of Increasing Doses of GK Activator (2) in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent.

Brief summary

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

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of \<100mg/dL. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Study identification

NCT ID
NCT00366379
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
127 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 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
Jun 30, 2006
Primary completion
May 31, 2007
Completion
May 31, 2007
Last update posted
Nov 1, 2016

2006 – 2007

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Not listed Chandler Arizona 85225
Not listed Oviedo Florida 32765
Not listed Nampa Idaho 83687
Not listed Evansville Indiana 47714
Not listed Butte Montana 59701
Not listed Canton Ohio 44718
Not listed Portland Oregon 97239
Not listed Greer South Carolina 29651
Not listed Midland Texas 79707
Not listed Richmond Virginia 23249

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 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00366379, 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 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00366379 live on ClinicalTrials.gov.

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