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NCT00495469 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT00495469: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00495469 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00495469, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus
Primary Outcome
The blood samples were collected at Baseline, Week 4, Week 8 and at Week 12 (or early withdrawal). Baseline was defined as the period immediately preceding treatment with study medication (Week 0). For participants with missing Baseline assessment, the last pre-therapy value prior to the Baseline visit was used as the Baseline value. Change from Baseline was the value at Week 12 minus Baseline value. The primary analysis was performed on the Intent-to-Treat (ITT) Population with Last observation
Interventions
- DRUG Placebo
- DRUG GSK189075
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2007-08-17 |
| Est. Completion | 2008-06-05 |
| Phase | Phase 2 |
What the finished NCT00495469 record still lists
NCT00495469 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (88% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00495469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00495469 about?
NCT00495469 is a clinical study titled "Dose-Ranging Study In Subjects With Type 2 Diabetes Mellitus Who Are Treatment-Naive". This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of GSK189075 (an SGLT2 inhibitor) compared to placebo, administered over 12 weeks in treatment-naive subjects with type 2 diabetes mellitus
What is the current status of trial NCT00495469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2007-08-17. Estimated completion is 2008-06-05.
What interventions are being tested in trial NCT00495469?
The interventions under investigation include: Placebo (DRUG), GSK189075 (DRUG).
Who is sponsoring clinical trial NCT00495469?
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 NCT00495469's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 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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