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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455896
First Posted: October 20, 2011
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intarcia Therapeutics
October 18, 2011
October 20, 2011
January 27, 2017
March 2013
March 2016   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01455896 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ITCA 650
    ITCA 650
  • Other: ITCA placebo
    ITCA placebo
  • Experimental: ITCA 650 60 mcg/day
    ITCA 650 is exenatide in DUROS
    Intervention: Drug: ITCA 650
  • ITCA placebo
    Intervention: Other: ITCA placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4156
March 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • history of pancreatitis
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Denmark,   Finland,   Germany,   Poland,   Slovakia,   South Africa,   Turkey,   United States
 
 
NCT01455896
ITCA 650-CLP-107
Yes
Not Provided
Not Provided
Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP