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Trial · Interventional

CompletedPhase 3Registry data

A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

NCTNCT01455896 (opens ClinicalTrials.gov in a new tab)Other idITCA 650-CLP-107
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Exenatide (exendin-4), does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 3
Enrollment
4,156 participants (actual)
Sponsor
Intarcia Therapeutics · Industry
Design
Randomized · Quadruple masking
Countries
9 countries

United States, Bulgaria, Denmark, Finland, Germany, Poland, Slovakia, South Africa, Turkey (Türkiye)

Start
Mar 2013
Primary completion
Mar 2016
Completion
Mar 2016
First posted
20 Oct 2011 (estimated)
Last update posted
27 Jan 2017 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 3

    A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

    NCT01455896

    Mar 2013 to Mar 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.

Interventions

  • ITCA 650Drug
  • ITCA placeboOther

Arms2

  • Experimental

    ITCA 650 60 mcg/day

    ITCA 650 is exenatide in DUROS

  • Other

    ITCA placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina),

    Time frame · 2 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

4 results

Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial.

Ruff et al. 2022Nature medicinecited by 85

PMID 34873344DOI 10.1038/s41591-021-01584-3PUB-34873344

Full text at the publisher4 results
Publisher pageSee results (4)

More studies

1 study on this page

PubMed tag: none · 2018

Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.

Wittbrodt et al. 2018The American journal of managed carecited by 21

PMID 29693361PUB-29693361

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * HBA1c \> 6.5% * History of coronary, cerebrovascular or peripheral artery disease Exclusion Criteria: * history of pancreatitis

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