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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.

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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

FieldValue
Enrollment Target 688 participants
Start Date 2006-10
Est. Completion 2009-09
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.