Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
NCT ID: NCT02638805
Last Updated: 2018-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
136 participants
INTERVENTIONAL
2015-12-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
ITCA 650 20/60 mcg/day
ITCA 650 Osmotic Mini Pump 20/60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
Metformin
Stable dose for at least 3 months (at least 1000 mg/day)
Liraglutide
Stable dose for at least 3 months (at least 1.2 mg/day)
Group 2
ITCA 650 60 mcg/day
ITCA 650 Osmotic Mini Pump 60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
Metformin
Stable dose for at least 3 months (at least 1000 mg/day)
Liraglutide
Stable dose for at least 3 months (at least 1.2 mg/day)
Interventions
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ITCA 650 Osmotic Mini Pump 20/60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
ITCA 650 Osmotic Mini Pump 60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
Metformin
Stable dose for at least 3 months (at least 1000 mg/day)
Liraglutide
Stable dose for at least 3 months (at least 1.2 mg/day)
Eligibility Criteria
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Inclusion Criteria
* Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
* HbA1c ≤9.5%.
* Stable body weight ≥ 3 months.
* Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
* Calcitonin \<50 ng/L (50 pg/mL) at the Screening Visit.
Exclusion Criteria
* Recent use or of anti-diabetic medications other than liraglutide or metformin.
* History of significant/severe nausea and/or vomiting due to liraglutide.
* Significant symptomatic hyperglycemia.
* History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
* History or evidence of acute or chronic pancreatitis.
* History of liver disease.
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
* Poor thyroid, liver, or renal function.
* Serum creatinine levels \>1.5mg/dL (132 μmol/L) for male patients, or \>1.4 mg/dL (123 μmol/L) for female patients.
* Weight loss surgery or requires weight loss medications.
* History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).
* History of active alcohol or substance abuse.
* Treatment with medications that affect GI motility.
* History of hypersensitivity to exenatide or liraglutide.
* Women that are pregnant, lactating, or planning to become pregnant.
18 Years
80 Years
ALL
No
Sponsors
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Intarcia Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Sensible Healthcare, LLC
Ocoee, Florida, United States
Solaris Clinical Research
Meridian, Idaho, United States
American Health Network of Indiana, LLC
Avon, Indiana, United States
American Health Network of Indiana, LLC
Franklin, Indiana, United States
American Health Network of Indiana, LLC
Greenfield, Indiana, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Center for Advanced Medical Research
City of Saint Peters, Missouri, United States
Radiant Research
St Louis, Missouri, United States
Accent Clinical Trials
Las Vegas, Nevada, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Manhattan Medical Research
New York, New York, United States
Novel Research of New York
The Bronx, New York, United States
Carteret Medical Group, LLC
Morehead City, North Carolina, United States
Prestige Clinical Research
Franklin, Ohio, United States
Lynn Institute of the Oz
Norman, Oklahoma, United States
LION Research
Norman, Oklahoma, United States
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States
Coastal Bend Clinical Research
Corpus Christi, Texas, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Panacea Clinical Research, LLC
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Victorium Clinical Research Ltd.
San Antonio, Texas, United States
Erickson Research and Development
Clinton, Utah, United States
Countries
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Other Identifiers
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ITCA 650-CLP-201
Identifier Type: -
Identifier Source: org_study_id
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