Clinical trial NCT01455896: 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 Patients Treated With Standard of Care for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 4156
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* history of pancreatitis

Primary outcomes:
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),
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Study Site
state: Arizona
city: Hayward
country: United States
facility: Intarcia Therapeutics, Inc
state: California
city: Long Beach
country: United States
facility: Study Site
state: California
city: Port Hueneme
country: United States
facility: Study Site
state: California
city: San Diego
country: United States
facility: Study SIte
state: California
city: Bradenton
country: United States
facility: Study Site
state: Florida
city: New Port Richey
country: United States
facility: Study Site
state: Florida
city: Palm Harbor
country: United States
facility: Study Site
state: Florida
city: Chicago
country: United States
facility: Study Site
state: Illinois
city: Avon
country: United States
facility: Study Site
state: Indiana
city: Evansville
country: United States
facility: Study Site
state: Indiana
city: Franklin
country: United States
facility: Study Site
state: Indiana
city: Greenfield
country: United States
facility: Study Site
state: Indiana
city: Muncie
country: United States
facility: Study Site
state: Indiana
city: Newton
country: United States
facility: Study Site
state: Kansas
city: Wichita
country: United States
facility: Study Site
state: Kansas
city: Wichita
country: United States
facility: Study Site
state: Kansas
city: Metaire
country: United States
facility: Study Site
state: Louisiana
city: Rochester
country: United States
facility: Study Site
state: Michigan
city: St Louis
country: United States
facility: Study Site
state: Missouri
city: Billings
country: United States
facility: Study Site
state: Montana
city: Las Vegas
country: United States
facility: Study Site
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Winston-Salem
country: United States
facility: Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Study Site
state: Ohio
city: Columbus
country: United States
facility: Study Site
state: Ohio
city: Franklin
country: United States
facility: Study Site
state: Ohio
city: Pittsburgh
country: United States
facility: Study Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Study Site
state: Pennsylvania
city: Greer
country: United States
facility: Study Site
state: South Carolina
city: Austin
country: United States
facility: Study Site
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
facility: Study Site
state: Texas
city: San Antonio
country: United States
facility: Study Site
state: Texas
city: Plovdiv
country: Bulgaria
city: Hvidovre
country: Denmark
city: Oulu
country: Finland
city: Bad Lauterberg im Harz
country: Germany
state: Niedersachsen
city: Sopot
country: Poland
city: Martin
country: Slovakia
city: Johannesburg
country: South Africa
state: Gauteng
city: Istanbul
country: Turkey
Study officials:
References:
citation: Ruff CT, Baron M, Im K, O'Donoghue ML, Fiedorek FT, Sabatine MS. Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial. Nat Med. 2022 Jan;28(1):89-95. doi: 10.1038/s41591-021-01584-3. Epub 2021 Dec 6.
citation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.