ClinicalTrials.gov
History of Changes for Study: NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Latest version (submitted January 26, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 19, 2011 None (earliest Version on record)
2 October 20, 2011 Study Status and Study Identification
3 November 9, 2011 Study Status and Eligibility
4 March 21, 2012 Study Status and Arms and Interventions
5 April 27, 2012 Study Status, Contacts/Locations, Eligibility, Arms and Interventions and Study Identification
6 October 18, 2012 Study Status
7 April 8, 2013 Recruitment Status, Study Status, Contacts/Locations and Oversight
8 April 9, 2013 Contacts/Locations and Study Status
9 July 26, 2013 Contacts/Locations and Study Status
10 April 16, 2014 Study Status and Contacts/Locations
11 November 14, 2014 Study Status and Study Design
12 July 29, 2015 Recruitment Status, Study Status and Contacts/Locations
13 June 3, 2016 Study Status, Arms and Interventions
14 January 26, 2017 Recruitment Status, Study Status and Study Design
Comparison Format:
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Study NCT01455896
Submitted Date:  October 19, 2011 (v1)
Open or close this module Study Identification
Unique Protocol ID: ITCA 650-CLP-07
Brief Title: A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Official Title: A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Subjects Treated With Standard of Care for Type 2 Diabetes
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2011
Overall Status: Not yet recruiting
Study Start: January 2012
Primary Completion: July 2014 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: October 18, 2011
First Submitted that
Met QC Criteria:		 October 19, 2011
First Posted: October 20, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		 October 19, 2011
Last Update Posted: October 20, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Intarcia Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.
Detailed Description:
Open or close this module Conditions
Conditions: Type 2 Diabetes
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 2000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
 Drug: ITCA 650
ITCA placebo
ITCA placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
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 ]
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • HBA1c between 6.5% - 11%
  • History of coronary, cerebrovascular or peripheral artery disease

Exclusion Criteria:

  • history of pancreatitis
Open or close this module Contacts/Locations
Central Contact Person: Kenneth Luskey, MD
Email: clinicaltrials@intarcia.com
Locations: United States, California
Intarcia Therapeutics, Inc
Hayward, California, United States, 94545
Contact:Contact: Kenneth Luskey, MD clinicaltrials@intarcia.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services