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Clinical Trial Details

Trial ID: L7066
Source ID: NCT02638805
Associated Drug: Itca 650 Osmotic Mini Pump 20/60 Mcg/Day
Title: Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: ITCA 650 Osmotic Mini Pump 20/60 mcg/day|DRUG: ITCA 650 Osmotic Mini Pump 60 mcg/day|DRUG: Metformin|DRUG: Liraglutide
Outcome Measures: Primary: 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., From Randomization to 34 weeks | Secondary: 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, From Randomization to 34 weeks|Incidence of hypoglycemia, From Randomization to 34 weeks|Change in percentage of glycosylated hemoglobin (HbA1c) in the blood, From baseline to Week 26|Change in body weight, Change from baseline in body weight at Week 26, from baseline to Week 26 | Other: Change from baseline in blood pressure and heart rate, Change from baseline in blood pressure and heart rate at Week 26, from baseline to 34 weeks|Change from baseline in fasting plasma glucose, from baseline to Week 26|Change from baseline in cholesterol, Change in low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), from baseline to Week 26
Sponsor/Collaborators: Sponsor: Intarcia Therapeutics
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 136
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-12
Completion Date: 2017-10
Results First Posted:
Last Update Posted: 2018-11-05
Locations: Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, 35235, United States|Saint Vincent's Medical Center (BRANY), Gulf Shores, Alabama, 36542, United States|Arkansas Primary Care Clinic, PA, Little Rock, Arkansas, 72204, United States|University of Colorado Hospital, Aurora, Colorado, United States|Denver VA Medical Center, Denver, Colorado, 80220, United States|Meridien Research, Brooksville, Florida, 34601, United States|International Research Associates, LLC, Hialeah, Florida, 33012, United States|Care Partners Clinical Research, LLC, Jacksonville, Florida, 32218, United States|AMPM Research Clinic, Miami, Florida, 33145, United States|Epocrates Medical and Research Center, Miami, Florida, 33175, United States|Sensible Healthcare, LLC, Ocoee, Florida, 34761, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|American Health Network of Indiana, LLC, Avon, Indiana, 46123, United States|American Health Network of Indiana, LLC, Franklin, Indiana, 46131, United States|American Health Network of Indiana, LLC, Greenfield, Indiana, 46140, United States|Cotton-O'Neil Clinical Research Center, Topeka, Kansas, 66606, United States|University of Massachusetts Medical School, Worcester, Massachusetts, 01655, United States|Radiant Research, Saint Louis, Missouri, 63141, United States|Center for Advanced Medical Research, Saint Peters, Missouri, 63303, United States|Accent Clinical Trials, Las Vegas, Nevada, 89119, United States|Palm Research Center, Inc., Las Vegas, Nevada, 89148, United States|Novel Research of New York, Bronx, New York, 10461, United States|Manhattan Medical Research, New York, New York, 10016, United States|Carteret Medical Group, LLC, Morehead City, North Carolina, 28557, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Lynn Institute of the Oz, Norman, Oklahoma, 73069, United States|LION Research, Norman, Oklahoma, 73072, United States|University of Tennessee Health Sciences Center, Memphis, Tennessee, 38103, United States|Coastal Bend Clinical Research, Corpus Christi, Texas, 78414, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, 75230, United States|Juno Research, LLC, Houston, Texas, 77036, United States|Sante Clinical Research, Kerrville, Texas, 78028, United States|Panacea Clinical Research, LLC, San Antonio, Texas, 78228, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Victorium Clinical Research Ltd., San Antonio, Texas, 78229, United States|Erickson Research and Development, Clinton, Utah, 84015, United States
URL: https://clinicaltrials.gov/show/NCT02638805

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details