Study S002013

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With 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: NCT01455857
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 460
Start: 2013-03
Primary completion: 2014-08
Lead sponsor: Intarcia Therapeutics
Conditions: Type 2 Diabetes
Interventions: DRUG:ITCA 650; OTHER:ITCA placebo
Results posted: FALSE

Registered primary outcomes

Change in HbA1c [39 weeks]

Linked records (1)

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
R0015574	Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial. Rosenstock J, Diabetes care	2018	Randomized trial	PMID 29242349 DOI	cites ClinicalTrials.gov:NCT01455857; registry reference DERIVED:29242349