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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455896

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

  Hide Study Locations
Locations
United States, Arizona
Study Site Recruiting
Chandler, Arizona, United States, 85224
United States, California
Intarcia Therapeutics, Inc Not yet recruiting
Hayward, California, United States, 94545
Contact: Michelle Baron, MD, FACE       clinicaltrials@intarcia.com   
Study Site Recruiting
Long Beach, California, United States, 90806
Study Site Recruiting
Port Hueneme, California, United States, 93041
Study SIte Recruiting
San Diego, California, United States, 92114
United States, Florida
Study Site Recruiting
Bradenton, Florida, United States, 34208
Study Site Recruiting
New Port Richey, Florida, United States, 34652
Study Site Recruiting
Palm Harbor, Florida, United States, 34684
United States, Illinois
Study Site Recruiting
Chicago, Illinois, United States, 60634
United States, Indiana
Study Site Recruiting
Avon, Indiana, United States, 46123
Study Site Recruiting
Evansville, Indiana, United States, 47714
Study Site Recruiting
Franklin, Indiana, United States, 46131
Study Site Recruiting
Greenfield, Indiana, United States, 46140
Study Site Recruiting
Muncie, Indiana, United States, 47304
United States, Kansas
Study Site Recruiting
Newton, Kansas, United States, 67114
Study Site Recruiting
Wichita, Kansas, United States, 67205
Study Site Recruiting
Wichita, Kansas, United States, 67207
United States, Louisiana
Study Site Recruiting
Metaire, Louisiana, United States, 70006
United States, Michigan
Study Site Not yet recruiting
Rochester, Michigan, United States, 48307
United States, Missouri
Study Site Recruiting
St Louis, Missouri, United States, 63141
United States, Montana
Study Site Recruiting
Billings, Montana, United States, 59101
United States, Nevada
Study Site Recruiting
Las Vegas, Nevada, United States, 89128
Recruiting
Las Vegas, Nevada, United States, 89148
United States, North Carolina
Study Site Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Study Site Recruiting
Cincinnati, Ohio, United States, 45236
Study Site Recruiting
Columbus, Ohio, United States, 43213
Study Site Recruiting
Franklin, Ohio, United States, 45005
United States, Pennsylvania
Study Site Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Study Site Recruiting
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Study Site Recruiting
Greer, South Carolina, United States, 29651
United States, Texas
Study Site Recruiting
Austin, Texas, United States, 78745
Study Site Recruiting
Dallas, Texas, United States, 75231
Recruiting
Dallas, Texas, United States, 75230
Study Site Recruiting
San Antonio, Texas, United States, 78229
Bulgaria
Recruiting
Plovdiv, Bulgaria, 4002
Denmark
Recruiting
Hvidovre, Denmark, 2650
Finland
Recruiting
Oulu, Finland, 90100
Germany
Recruiting
Bad Lauterberg im Harz, Niedersachsen, Germany, 37431
Poland
Recruiting
Sopot, Poland, 81-717
Slovakia
Recruiting
Martin, Slovakia, 03659
South Africa
Recruiting
Johannesburg, Gauteng, South Africa, 2193
Turkey
Not yet recruiting
Istanbul, Turkey, 34098
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 16, 2014
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
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 27, 2014