Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 7:36 AM
Study NCT ID:
NCT01455857
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2011-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
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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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HbA1c between 7.5% - 10%\n* On diet \\& exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU\n* BMI between 25 \\& 45 kg/m2\n\nExclusion Criteria:\n\n* taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months\n* history of pancreatitis'}, 'identificationModule': {'nctId': 'NCT01455857', 'briefTitle': 'A Study to Evaluate ITCA 650 for the Treatment of 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