Study S000677

A Randomized, Multi-Center Study to Evaluate Cardiovascular Outcomes With ITCA 650 in Patients Treated With Standard of Care for Type 2 Diabetes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT01455896
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 4156
Start: 2013-03
Primary completion: 2016-03
Lead sponsor: Intarcia Therapeutics
Conditions: Type 2 Diabetes
Interventions: DRUG:ITCA 650; OTHER:ITCA placebo
Results posted: FALSE

Registered primary outcomes

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), [2 years]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0006153	Subcutaneous infusion of exenatide and cardiovascular outcomes in type 2 diabetes: a non-inferiority randomized controlled trial. Ruff CT, Nature medicine	2022	Randomized trial	PMID 34873344 DOI	cites ClinicalTrials.gov:NCT01455896; registry reference DERIVED:34873344
R0007117	Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Wittbrodt ET, The American journal of managed care	2018	Nonrandomized study	PMID 29693361	cites ClinicalTrials.gov:NCT01455896; registry reference DERIVED:29693361
R0049736	Implications of cardiovascular outcome trials with injectable antidiabetic agents Richard E. Pratley, Journal of Diabetes	2018	Randomized trial	PMID 29971941 DOI	cites ClinicalTrials.gov:NCT01455896