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NCT00366379 · ClinicalTrials.gov registry record · Phase 2

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

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

Completed
Registry status
Phase 2
Development phase
127
Enrollment target

NCT00366379: Completed Phase 2 study, sponsored by Hoffmann-La Roche.

NCT00366379 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00366379, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
127 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG GK Activator (2)

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2006-07
Est. Completion 2007-06
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT00366379 record still lists

NCT00366379 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which GK Activator (2) is the first listed.

NCT00366379 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00366379 about?

NCT00366379 is a clinical study titled "A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.". 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, pat...

What is the current status of trial NCT00366379?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2006-07. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00366379?

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

Who is sponsoring clinical trial NCT00366379?

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 NCT00366379's enrollment target sits among peer trials

127 555th of 2000 higher than 1,445 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 NCT00366379, the US trial registry maintained by the National Library of Medicine. NCT00366379 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.