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NCT02229396 · ClinicalTrials.gov registry record · Phase 3

Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

A Phase 3 study of Diabetes Mellitus, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
695
Enrollment target
20
Study locations

NCT02229396 is a Phase 3 study of Diabetes Mellitus that has completed, run by AstraZeneca. The registered enrollment target is 695 participants, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 4 states.

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The verdict

NCT02229396, a Phase 3 study of Diabetes Mellitus, has completed, sponsored by AstraZeneca.

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

Study Summary

Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.

Conditions Studied

Diabetes Mellitus

Interventions

  • DRUG Dapagliflozin
  • DRUG Exantide with Dapagliflozin
  • DRUG Exentide

Study Locations (20)

California

  • Research Site - Anaheim
  • Research Site - Chula Vista
  • Research Site - El Cajon
  • Research Site - Fresno
  • Research Site - La Mesa
  • Research Site - Long Beach
  • Research Site - Los Angeles
  • Research Site - Mission Hills
  • Research Site - Montclair
  • Research Site - Oceanside
  • Research Site - San Diego
  • Research Site - San Diego
  • Research Site - Tustin
  • Research Site - Van Nuys

Alabama

  • Research Site - Birmingham
  • Research Site - Huntsville
  • Research Site - Tuscumbia

Arizona

  • Research Site - Glendale
  • Research Site - Tempe

Florida

  • Research Site - Boynton Beach

Trial Details

FieldValue
Enrollment Target 695 participants
Start Date 2014-09-04
Est. Completion 2017-12-28
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02229396

The ClinicalTrials.gov registry entry for NCT02229396 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 695 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,864-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (63% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Dapagliflozin is the first listed.

NCT02229396 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT02229396 about?

NCT02229396 is a clinical study titled "Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo". Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone a...

What is the current status of trial NCT02229396?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 695 participants. The study started on 2014-09-04. Estimated completion is 2017-12-28.

What conditions does trial NCT02229396 study?

This clinical trial studies the following conditions: Diabetes Mellitus.

What interventions are being tested in trial NCT02229396?

The interventions under investigation include: Dapagliflozin (DRUG), Exantide with Dapagliflozin (DRUG), Exentide (DRUG).

Who is sponsoring clinical trial NCT02229396?

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

Where is trial NCT02229396 being conducted?

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