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ITCA 650

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https://www.readbyqxmd.com/read/24631129/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
#1
RANDOMIZED CONTROLLED TRIAL
Robert R Henry, Julio Rosenstock, Douglas Logan, Thomas Alessi, Kenneth Luskey, Michelle A Baron
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...
May 2014: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/23645886/randomized-trial-of-continuous-subcutaneous-delivery-of-exenatide-by-itca-650-versus-twice-daily-exenatide-injections-in-metformin-treated-type-2-diabetes
#2
RANDOMIZED CONTROLLED TRIAL
Robert R Henry, Julio Rosenstock, Douglas K Logan, Thomas R Alessi, Kenneth Luskey, Michelle A Baron
OBJECTIVE: To evaluate ITCA 650, a continuous subcutaneous miniature osmotic pump delivery system of exenatide versus twice-daily exenatide injections (Ex-BID) in subjects with type 2 diabetes. RESEARCH DESIGN AND METHODS: We conducted a randomized, two-stage, 24-week, open-label, phase 2 study in type 2 diabetes inadequately controlled with metformin. Stage I: 155 subjects were randomized to 20 or 40 μg/day of ITCA 650 or Ex-BID 5 → 10 μg. Stage II: 131 subjects were rerandomized to 20, 40, 60, or 80 μg/day of ITCA 650...
September 2013: Diabetes Care
https://www.readbyqxmd.com/read/23578605/a-randomized-open-label-multicenter-4-week-study-to-evaluate-the-tolerability-and-pharmacokinetics-of-itca-650-in-patients-with-type-2-diabetes
#3
RANDOMIZED CONTROLLED TRIAL
Robert R Henry, Douglas Logan, Thomas Alessi, Michelle A Baron
BACKGROUND: Exenatide, a glucagon-like peptide-1 receptor agonist administered by self-injection, decreases plasma glucose, glycosylated hemoglobin (HbA1c), and weight in patients with type 2 diabetes. ITCA 650 is an investigational new drug that provides continuous subcutaneous delivery of exenatide. OBJECTIVE: This randomized, open-label, multicenter, 28-day study evaluated the tolerability, pharmacodynamics, and pharmacokinetics of ITCA 650 in patients with type 2 diabetes...
May 2013: Clinical Therapeutics
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