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NCT00386100 · ClinicalTrials.gov registry record · Phase 4
A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 688
- Enrollment target
NCT00386100: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT00386100 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 688 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386100, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 688 participants
- Enrollment target
Study Summary
This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to look at changes in bone mineral density (BMD) at the lumbar spine.
Primary Outcome
Blood was taken for serum HbA1c measurements. Change from baseline was calculated as the Week 80 value minus the baseline value. Last observation carried forward (LOCF) was not used for this analysis.
Interventions
- DRUG Avandamet 6 mg/1500 mg (ttd)
- DRUG Avandamet 4 mg/1000 mg (ttd)
- DRUG Avandamet 2 mg/500 mg (ttd)
- DRUG Avandamet 8 mg/ 2000 mg (ttd)
- DRUG Metformin 500 mg (ttd)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 688 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-09 |
| Phase | Phase 4 |
What the finished NCT00386100 record still lists
NCT00386100 is an interventional study that assigns participants to a tested intervention. The registered 688 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 5 interventions - of which Avandamet 6 mg/1500 mg (ttd) is the first listed.
NCT00386100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00386100 about?
NCT00386100 is a clinical study titled "A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. Metformin". This study will evaluate the longer-term glycemic effect of two medicines approved for initial treatment of type 2 diabetes. The study consists of a 2 week screening period (2 study visits), followed by an 80 week double-blind treatment period (11 study visits). Also, a sub-study was included to loo...
What is the current status of trial NCT00386100?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 688 participants. The study started on 2006-10. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00386100?
The interventions under investigation include: Avandamet 6 mg/1500 mg (ttd) (DRUG), Avandamet 4 mg/1000 mg (ttd) (DRUG), Avandamet 2 mg/500 mg (ttd) (DRUG), Avandamet 8 mg/ 2000 mg (ttd) (DRUG), Metformin 500 mg (ttd) (DRUG).
Who is sponsoring clinical trial NCT00386100?
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 NCT00386100's enrollment target sits among peer trials
688 119th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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