A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
Stable dose for at least 3 months (at least 1000 mg/day)
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.
Time frame: From Randomization to 34 weeks
Number (percentage) and severity of all treatment-emergent adverse events
All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide
Time frame: From Randomization to 34 weeks
Incidence of hypoglycemia
Time frame: From Randomization to 34 weeks
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
Time frame: From baseline to Week 26
Change in body weight
Change from baseline in body weight at Week 26
Time frame: from baseline to Week 26
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Stable dose for at least 3 months (at least 1.2 mg/day)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Saint Vincent's Medical Center (BRANY)
Gulf Shores, Alabama, United States
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver VA Medical Center
Denver, Colorado, United States
Meridien Research
Brooksville, Florida, United States
International Research Associates, LLC
Hialeah, Florida, United States
Care Partners Clinical Research, LLC
Jacksonville, Florida, United States
AMPM Research Clinic
Miami, Florida, United States
Epocrates Medical and Research Center
Miami, Florida, United States
...and 26 more locations