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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 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 688 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00386100
The ClinicalTrials.gov registry entry for NCT00386100 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 688 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Avandamet 6 mg/1500 mg (ttd) is the first listed.
NCT00386100 reports 0 study locations.
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.
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