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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Intarcia Therapeutics
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455896
First received: October 18, 2011
Last updated: April 16, 2014
Last verified: April 2014

October 18, 2011
April 16, 2014
March 2013
July 2018   (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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: ITCA 650
    exenatide in DUROS
    Other Name: placebo in DUROS
  • Other: ITCA placebo
    placebo in DUROS
  • 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.
 
Recruiting
2000
July 2018
July 2018   (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
Both
40 Years and older
No
Contact: Michelle Baron, MD, FACE clinicaltrials@intarcia.com
United States,   Bulgaria,   Denmark,   Finland,   Germany,   Poland,   Slovakia,   South Africa,   Turkey
 
NCT01455896
ITCA 650-CLP-107
Yes
Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
April 2014

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