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NCT00643851 · ClinicalTrials.gov registry record · Phase 3

An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

A Phase 3 study of Type 2 Diabetes, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
994
Enrollment target
20
Study locations

NCT00643851 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 994 participants, below the 1,099-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00643851, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
994 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied

Conditions Studied

Interventions

  • DRUG Dapagliflozin
  • DRUG Metformin XR

Study Locations (20)

Florida

  • Central Florida Clinical Trials, Inc. - Altamonte Springs
  • Clinical Therapeutics Corporation - Coral Gables
  • Florida Research Network, Llc - Gainesville
  • Fpa Clinical Research - Kissimmee
  • Nextphase Clinical Trials, Inc. - Miami

California

  • John Muir Physician Network Clinical Research Center - Concord
  • Southland Clinical Research Center, Inc. - Fountain Valley
  • Valley Research - Fresno

Alabama

  • Greystone Medical Research, Llc - Birmingham
  • Winston Technology Research, Llc - Haleyville

Illinois

  • Cedar Crosse Research Center - Chicago
  • Deerbrook Medical Associates - Vernon Hills

North Carolina

  • Metrolina Medical Research - Charlotte
  • Crescent Medical Research - Salisbury

Arizona

  • Clinical Research Advantage, Inc. - Tempe

Georgia

  • Middle Georgia Drug Study Center, Llc - Perry

Mississippi

  • Jackson Clinic - Rolling Fork

Trial Details

FieldValue
Enrollment Target 994 participants
Start Date 2008-06
Est. Completion 2009-08
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00643851

The ClinicalTrials.gov registry entry for NCT00643851 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 994 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,099-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (10% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Dapagliflozin is the first listed.

NCT00643851 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT00643851 about?

NCT00643851 is a clinical study titled "An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets". The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatm...

What is the current status of trial NCT00643851?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 994 participants. The study started on 2008-06. Estimated completion is 2009-08.

What conditions does trial NCT00643851 study?

This clinical trial studies the following conditions: Type 2 Diabetes.

What interventions are being tested in trial NCT00643851?

The interventions under investigation include: Dapagliflozin (DRUG), Metformin XR (DRUG).

Who is sponsoring clinical trial NCT00643851?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00643851 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.