title: Continuous subcutaneous delivery of exenatide via ITCA 650 leads to sustained glycemic control and weight loss for 48 weeks in metformin-treated subjects with type 2 diabetes.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: VA San Diego Healthcare System, San Diego, CA and University of California, San Diego, La Jolla, CA. Electronic address: rrhenry@vapop.ucsd.edu.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Henry
authors.affiliation: Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX.
authors.forename: Julio
authors.initials: J
authors.lastname: Rosenstock
authors.affiliation: Medpace Clinical Pharmacology Unit, Cincinnati, OH.
authors.forename: Douglas
authors.initials: D
authors.lastname: Logan
authors.affiliation: Intarcia Therapeutics Inc., Hayward, CA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Alessi
authors.affiliation: Intarcia Therapeutics Inc., Hayward, CA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Luskey
authors.affiliation: Intarcia Therapeutics Inc., Hayward, CA.
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Baron
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects / Q000502:physiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D000077270:Exenatide; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D055104:Infusions, Subcutaneous; D008137:Longitudinal Studies; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010455:Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome; D014688:Venoms / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D015431:Weight Loss / Q000187:drug effects* / Q000502:physiology
chemical_list: D001786:Blood Glucose; D000077270:Exenatide; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010455:Peptides; D014688:Venoms
keywords: Exenatide; ITCA 650; Type 2 diabetes