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NCT00918138 · ClinicalTrials.gov registry record · Phase 3

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

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

Completed
Registry status
Phase 3
Development phase
219
Enrollment target
20
Study locations

NCT00918138 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 219 participants, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00918138, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.

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

Study Summary

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Conditions Studied

Interventions

  • DRUG Saxagliptin
  • DRUG Metformin XR
  • DRUG Placebo matching Metformin XR
  • DRUG Placebo matching Saxagliptin

Study Locations (20)

Other

  • Local Institution - Beersheba
  • Local Institution - Holon
  • Local Institution - Kfar Saba
  • Local Institution - Safed

Florida

  • Clinical Research Of South Florida - Coral Gables
  • Palm Springs Research Institute - Hialeah
  • Healthcare Clinical Data, Inc. - North Miami

California

  • Pacific Sleep Medicine Services (Avastra Clinical Trials) - Redlands
  • Orange County Research Center - Tustin

Buenos Aires

  • Local Institution - Buenos Aires
  • Local Institution - Capital Federal

Durango

  • Local Institution - Durango
  • Local Institution - Durango

Arizona

  • Dedicated Phase I, Inc. - Phoenix

Georgia

  • River Birch Research Alliance, Llc - Blue Ridge

Michigan

  • Jasper Clinic, Inc. - Kalamazoo

Trial Details

FieldValue
Enrollment Target 219 participants
Start Date 2009-08
Est. Completion 2010-05
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00918138

The ClinicalTrials.gov registry entry for NCT00918138 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 219 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (80% 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 4 interventions - of which Saxagliptin is the first listed.

NCT00918138 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT00918138 about?

NCT00918138 is a clinical study titled "Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg". The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

What is the current status of trial NCT00918138?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2009-08. Estimated completion is 2010-05.

What conditions does trial NCT00918138 study?

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

What interventions are being tested in trial NCT00918138?

The interventions under investigation include: Saxagliptin (DRUG), Metformin XR (DRUG), Placebo matching Metformin XR (DRUG), Placebo matching Saxagliptin (DRUG).

Who is sponsoring clinical trial NCT00918138?

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

Where is trial NCT00918138 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Michigan. 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.