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NCT00266253 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
220
Enrollment target

NCT00266253: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT00266253 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 220 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00266253, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
220 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Metformin
  • DRUG GK Activator (2)

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2005-11
Est. Completion 2007-03
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT00266253 record still lists

NCT00266253 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher).

The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.

NCT00266253 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00266253 about?

NCT00266253 is a clinical study titled "A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin". 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 ra...

What is the current status of trial NCT00266253?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2005-11. Estimated completion is 2007-03.

What interventions are being tested in trial NCT00266253?

The interventions under investigation include: Metformin (DRUG), GK Activator (2) (DRUG).

Who is sponsoring clinical trial NCT00266253?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00266253's enrollment target sits among peer trials

220 275th of 2000 higher than 1,718 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00266253, the US trial registry maintained by the National Library of Medicine. NCT00266253 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.