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Completed Phase 2 Interventional

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

ClinicalTrials.gov ID: NCT00266253

Public ClinicalTrials.gov record NCT00266253. 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 Oct 31, 2026, 6:28 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

A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin.

Brief summary

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

This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals.

Study identification

NCT ID
NCT00266253
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
220 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
Nov 2005 (Type not available)
Primary completion
Mar 2007 (Actual)
Completion
Mar 2007 (Actual)
Last update posted
Nov 2, 2016

2005 – 2007

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Not listed Phoenix Arizona 85012 —
Not listed Chula Vista California 91910 —
Not listed Los Angeles California 90057 —
Not listed Kissimmee Florida 34741 —
Not listed Tampa Florida 33603 —
Not listed Lawrenceville Georgia 30045 —
Not listed Arkansas City Kansas 67005 —
Not listed Benzonia Michigan 49616 —
Not listed Springfield Missouri 65804 —
Not listed Butte Montana 59701 —
Not listed Kettering Ohio 45429 —
Not listed Tulsa Oklahoma 74104 —
Not listed Medford Oregon 97504 —
Not listed Morrisville Pennsylvania 19067 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Memphis Tennessee 38119 —
Not listed Bellevue Washington 98004 —
Not listed Federal Way Washington 98003 —

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 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00266253, 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 2, 2016 · Synced Oct 31, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00266253 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →