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NCT01619059 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes

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

Completed
Registry status
Phase 3
Development phase
315
Enrollment target
20
Study locations

NCT01619059 is a Phase 3 study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 315 participants, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT01619059, a Phase 3 study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.

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

Study Summary

The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.

Conditions Studied

Interventions

  • DRUG Dapagliflozin
  • DRUG Saxagliptin
  • DRUG Metformin IR
  • DRUG Placebo matching with Saxagliptin

Study Locations (20)

California

  • Beach Physicians Clinical Research Corp. - Huntington Beach
  • Torrance Clinical Research - Lomita
  • Randall G. Shue, Do, Inc. - Los Angeles
  • National Research Institute - Los Angeles
  • Cassidy Medical Group/Clinical Research Advantage - Vista
  • Infosphere Clinical Research, Inc. - West Hills

Florida

  • Southeast Clinical Research, Llc - Chiefland
  • Clinical Therapeutics Corporation - Coral Gables
  • Medical Research Unlimited, Llc - Hialeah
  • University Of Florida Endocrinology & Diabetes - Jacksonville
  • Care Partners Clinical Research, Llc - Jacksonville
  • Clinical Research Of Miami, Inc. - Miami

Arizona

  • Mesa Family Medical Center - Mesa
  • Clinical Research Advantage Inc/Desert Clinical Research Llc - Mesa
  • Clinical Research Advantage, Inc - Phoenix
  • Clinical Research Advantage, Inc./ Stonecreek Medical Associates, Pc - Phoenix

Alabama

  • University Of Alabama At Birmingham - Birmingham
  • Terence T. Hart, Md - Muscle Shoals

Colorado

  • New West Physicians, Pc - Golden

Indiana

  • Clinical Research Advantage, Inc. - Evansville

Trial Details

FieldValue
Enrollment Target 315 participants
Start Date 2012-06
Est. Completion 2015-01
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01619059

The ClinicalTrials.gov registry entry for NCT01619059 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 315 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 (71% 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 Dapagliflozin is the first listed.

NCT01619059 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT01619059 about?

NCT01619059 is a clinical study titled "Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes". The purpose of this study is to learn if BMS-477118 (Saxagliptin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studi...

What is the current status of trial NCT01619059?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2012-06. Estimated completion is 2015-01.

What conditions does trial NCT01619059 study?

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

What interventions are being tested in trial NCT01619059?

The interventions under investigation include: Dapagliflozin (DRUG), Saxagliptin (DRUG), Metformin IR (DRUG), Placebo matching with Saxagliptin (DRUG).

Who is sponsoring clinical trial NCT01619059?

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

Where is trial NCT01619059 being conducted?

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