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

January 26, 2017 updated by: Intarcia Therapeutics

A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
  • Denmark
      • Hvidovre, Denmark, 2650
  • Finland
      • Oulu, Finland, 90100
  • Germany
    • Niedersachsen
      • Bad Lauterberg im Harz, Niedersachsen, Germany, 37431
  • Poland
      • Sopot, Poland, 81-717
  • Slovakia
      • Martin, Slovakia, 03659
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
  • Turkey
      • Istanbul, Turkey, 34098
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Study Site
    • California
      • Hayward, California, United States, 94545
        • Intarcia Therapeutics, Inc
      • Long Beach, California, United States, 90806
        • Study Site
      • Port Hueneme, California, United States, 93041
        • Study Site
      • San Diego, California, United States, 92114
        • Study Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Study Site
      • New Port Richey, Florida, United States, 34652
        • Study Site
      • Palm Harbor, Florida, United States, 34684
        • Study Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Study Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Study Site
      • Evansville, Indiana, United States, 47714
        • Study Site
      • Franklin, Indiana, United States, 46131
        • Study Site
      • Greenfield, Indiana, United States, 46140
        • Study Site
      • Muncie, Indiana, United States, 47304
        • Study Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Study Site
      • Wichita, Kansas, United States, 67205
        • Study Site
      • Wichita, Kansas, United States, 67207
        • Study Site
    • Louisiana
      • Metaire, Louisiana, United States, 70006
        • Study Site
    • Michigan
      • Rochester, Michigan, United States, 48307
        • Study Site
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Study Site
    • Montana
      • Billings, Montana, United States, 59101
        • Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
      • Las Vegas, Nevada, United States, 89128
        • Study Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Study Site
      • Columbus, Ohio, United States, 43213
        • Study Site
      • Franklin, Ohio, United States, 45005
        • Study Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Study Site
      • Uniontown, Pennsylvania, United States, 15401
        • Study Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Study Site
    • Texas
      • Austin, Texas, United States, 78745
        • Study Site
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75231
        • Study Site
      • San Antonio, Texas, United States, 78229
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBA1c > 6.5%
  • History of coronary, cerebrovascular or peripheral artery disease

Exclusion Criteria:

  • history of pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
Drug: ITCA 650
ITCA 650
Other: ITCA placebo
Other: ITCA placebo
ITCA placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intarcia Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCA 650-CLP-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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