Robert R Henry1, Julio Rosenstock2, Douglas Logan3, Thomas Alessi4, Kenneth Luskey4, Michelle A Baron4. 1. VA San Diego Healthcare System, San Diego, CA and University of California, San Diego, La Jolla, CA. Electronic address: rrhenry@vapop.ucsd.edu. 2. Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX. 3. Medpace Clinical Pharmacology Unit, Cincinnati, OH. 4. Intarcia Therapeutics Inc., Hayward, CA.
Abstract
AIMS: Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks. METHODS: This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled withmetformin. Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day). Mean changes for HbA1c, weight, and fasting plasma glucose (FPG) were evaluated. RESULTS:Mean changes in HbA1c from baseline to week 48 ranged from -0.85% to -1.51%. At week 48, ≥64% of subjects with an HbA1c ≤7% at week 24 maintained an HbA1c ≤7%. The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 μg/day to 37.5% with 80 μg/day. Most AEs were mild and transient; the incidence of nausea declined from 12.9% to 9.5% over the 24-week extension. One subject on ITCA 650 80 μg/day experienced mild intermittent vomiting. Three (3.5%) subjects experienced severe AEs, but none were considered related to study drug. CONCLUSION: Significant changes in HbA1c, body weight, and FPG attained with ITCA 650 were maintained to 48 weeks. The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase. Published by Elsevier Inc.
RCT Entities:
AIMS: Evaluate the efficacy and tolerability of ITCA 650 in subjects with type 2 diabetes treated for up to 48 weeks. METHODS: This was a 24-week extension to a randomized, 24-week, open-label, phase 2 study in subjects with type 2 diabetes inadequately controlled with metformin. Subjects received ITCA 650 mg (20, 40, 60 or 80 μg/day). Mean changes for HbA1c, weight, and fasting plasma glucose (FPG) were evaluated. RESULTS: Mean changes in HbA1c from baseline to week 48 ranged from -0.85% to -1.51%. At week 48, ≥64% of subjects with an HbA1c ≤7% at week 24 maintained an HbA1c ≤7%. The incidence of adverse events (AEs) was dose-related and ranged from 13.3% with 20 μg/day to 37.5% with 80 μg/day. Most AEs were mild and transient; the incidence of nausea declined from 12.9% to 9.5% over the 24-week extension. One subject on ITCA 650 80 μg/day experienced mild intermittent vomiting. Three (3.5%) subjects experienced severe AEs, but none were considered related to study drug. CONCLUSION: Significant changes in HbA1c, body weight, and FPG attained with ITCA 650 were maintained to 48 weeks. The incidence of AEs was lower in the 24-week extension than in the initial 24-week treatment phase. Published by Elsevier Inc.
Authors: William R Lykins; Ellen Luecke; Daniel Johengen; Ariane van der Straten; Tejal A Desai Journal: Drug Deliv Transl Res Date: 2017-12 Impact factor: 4.617
Authors: Minzhi Yu; Mason M Benjamin; Santhanakrishnan Srinivasan; Emily E Morin; Ekaterina I Shishatskaya; Steven P Schwendeman; Anna Schwendeman Journal: Adv Drug Deliv Rev Date: 2018-07-21 Impact factor: 15.470