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ITCA 650

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https://www.readbyqxmd.com/read/29301824/clinical-impact-of-itca-650-a-novel-drug-device-glp-1-receptor-agonist-in-uncontrolled-type-2-diabetes-and-very-high-baseline-hba1c-the-freedom-1-hbl-study
#1
Robert R Henry, Julio Rosenstock, Douglas S Denham, Prakash Prabhakar, Lise Kjems, Michelle A Baron
OBJECTIVE: ITCA 650 is a subdermal osmotic mini-pump that continuously delivers exenatide subcutaneously for 3-6 months. The efficacy, safety, and tolerability of ITCA 650 added to diet and exercise alone or combined with metformin, sulfonylurea, or thiazolidinedione monotherapy or a combination of these drugs was evaluated in poorly controlled patients with type 2 diabetes (T2D) who were ineligible for participation in a placebo-controlled study (FREEDOM-1) because of severe hyperglycemia (HbA1c >10% [86 mmol/mol])...
January 4, 2018: Diabetes Care
https://www.readbyqxmd.com/read/29242349/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
#2
Julio Rosenstock, John B Buse, Rehan Azeem, Prakash Prabhakar, Lise Kjems, Holly Huang, Michelle A Baron
OBJECTIVE: ITCA 650 (exenatide in osmotic mini-pump) continuously delivers exenatide subcutaneously for 3-6 months. Two doses of ITCA 650 were compared with placebo in patients with uncontrolled type 2 diabetes. RESEARCH DESIGN AND METHODS: This 39-week, phase 3, double-blind, placebo-controlled trial randomized 460 patients aged 18-80 years with glycated hemoglobin (HbA1c) 7.5-10% [58-86 mmol/mol] 1:1:1 to placebo, ITCA 650 40 μg/day, or ITCA 650 60 μg/day. Primary end point was change in HbA1c at 39 weeks...
February 2018: Diabetes Care
https://www.readbyqxmd.com/read/29053202/treatment-satisfaction-with-itca-650-a-novel-drug-device-delivering-continuous-exenatide-versus-twice-daily-injections-of-exenatide-in-type-2-diabetics-on-metformin
#3
Robert Henry, Julio Rosenstock, John F McCarthy, Ginger Carls, Tom Alessi, John Yee, Michelle Baron
AIMS: To evaluate treatment satisfaction in patients with type 2 diabetes (T2D), not adequately controlled by metformin, randomized to ITCA 650 (continuous exenatide in osmotic mini-pump) versus twice-daily exenatide injections (Ex-BID). MATERIALS AND METHODS: The Diabetes Medication Satisfaction Tool (DM-SAT) was administered and assessments made at baseline, week 8, and week 20 in a 24 week open-label phase 2 trial. In Stage I (weeks 1-12), 155 patients, comprising the ITT population, were randomized to three groups: ITCA 650 20 μg/day, ITCA 650 40 μg/day and Ex-BID 10 μg BID...
October 20, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27921428/-promising-molecules-for-treatment-of-hyperglycemia-in-patients-with-type-2-diabetes
#4
REVIEW
Milan Kvapil
New antidiabetic drugs are being developed today that expand the range of pharmacological intervention, in particular for patients with type 2 diabetes (imeglimin, semaglutide, dulaglutide, FGF 21 analogue). At the same time innovations take place that "better" the well-proven molecules, they offer new application forms we have no experience of diabetology (osmotic pump for exenatide, faster acting insulin aspart). New properties are brought by just the change of concentration (insulin glargine in a concentration of 300 U/ml), unexpected positive results are also brought by new fixed-ratio combinations of antidiabetics (fixed-ratio combination of insulin degludec and liraglutide, fixed-ratio combination of insulin glargine and lixisenatide)...
2016: Vnitr̆ní Lékar̆ství
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
#5
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
#6
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
#7
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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