A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

Summary

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

Timeline

Start

2013-03

Primary completion

2014-08

Completion

2014-09

Outcome

Met primary endpoint

paper change from baseline HbA1c was -1.1% [-12.2 mmol/mol] and -1.2% [-13.2 mmol/mol] for ITCA 650 40 and 60 μg/day, respectively (P < 0.001 vs. placebo PMID 29242349 ↗

Publications

• Rosenstock J, Buse JB, Azeem R, Prabhakar P, Kjems L, Huang H, Baron MA. 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. Diabetes Care. 2018 Feb;41(2):333-340. doi: 10.2337/dc17-1306. Epub 2017 Dec 14.

Drugs

Indications