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

This study is currently recruiting participants.
Verified April 2013 by Intarcia Therapeutics
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455896
First received: October 18, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
 Drug: ITCA 650
Other: ITCA placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: March 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
 Drug: ITCA 650
exenatide in DUROS
Other Name: placebo in DUROS
ITCA placebo Other: ITCA placebo
placebo in DUROS

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • history of pancreatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455896

Contacts
Contact: Michelle Baron, MD, FACE clinicaltrials@intarcia.com

  Show 32 Study Locations
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455896     History of Changes
Other Study ID Numbers: ITCA 650-CLP-107
Study First Received: October 18, 2011
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013