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NCT00111800 · ClinicalTrials.gov registry record · Phase 2
A New Oral Treatment For Type II Diabetes Mellitus
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 375
- Enrollment target
NCT00111800: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00111800 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 375 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (182% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00111800, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 375 participants
- Enrollment target
Study Summary
This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
Primary Outcome
HbA1c is used to show in participants with diabetes, how well their diabetes is being controlled. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected at Visit 5 (Week 0) and Visit 12 (Week 12). Baseline value was defined as the assessment done at Week 0. The change from Baseline was calculated by subtracting the Baseline value (Week 0) from the individual post-Baseline (Week 12) value. Analysis of covariance (
Interventions
- DRUG Placebo
- DRUG DEN 2.5 mg
- DRUG DEN 7.5 mg
- DRUG DEN 15 mg
- DRUG DEN 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2005-04-28 |
| Est. Completion | 2006-07-21 |
| Phase | Phase 2 |
What the finished NCT00111800 record still lists
NCT00111800 is an interventional study that assigns participants to a tested intervention. The registered 375 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 (182% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00111800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00111800 about?
NCT00111800 is a clinical study titled "A New Oral Treatment For Type II Diabetes Mellitus". This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
What is the current status of trial NCT00111800?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 375 participants. The study started on 2005-04-28. Estimated completion is 2006-07-21.
What interventions are being tested in trial NCT00111800?
The interventions under investigation include: Placebo (DRUG), DEN 2.5 mg (DRUG), DEN 7.5 mg (DRUG), DEN 15 mg (DRUG), DEN 30 mg (DRUG).
Who is sponsoring clinical trial NCT00111800?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00111800's enrollment target sits among peer trials
375 116th of 2000 higher than 1,883 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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