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COMPLETED 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

NCT02229396 · View on ClinicalTrials.gov ↗

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

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

1,053 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 695 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02229396 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02229396?

The interventions under investigation include: Dapagliflozin (DRUG), Exantide with Dapagliflozin (DRUG), Exentide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02229396?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial