Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/dayDrug: ITCA 650 Osmotic Mini Pump 60 mcg/day
- Registration Number
- NCT02638805
- Lead Sponsor
- Intarcia Therapeutics
- Brief Summary
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- Diagnosis of type 2 diabetes ≥ 3 months.
- 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.
- History of type 1 diabetes.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 ITCA 650 Osmotic Mini Pump 20/60 mcg/day ITCA 650 20/60 mcg/day Group 1 Metformin ITCA 650 20/60 mcg/day Group 1 Liraglutide ITCA 650 20/60 mcg/day Group 2 ITCA 650 Osmotic Mini Pump 60 mcg/day ITCA 650 60 mcg/day Group 2 Metformin ITCA 650 60 mcg/day Group 2 Liraglutide ITCA 650 60 mcg/day
- Primary Outcome Measures
Name Time Method Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting From Randomization to 34 weeks 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.
- Secondary Outcome Measures
Name Time Method Incidence of hypoglycemia From Randomization to 34 weeks Number (percentage) and severity of all treatment-emergent adverse events From Randomization to 34 weeks All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood From baseline to Week 26 Change in body weight from baseline to Week 26 Change from baseline in body weight at Week 26
Trial Locations
- Locations (34)
Coastal Bend Clinical Research
🇺🇸Corpus Christi, Texas, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Manhattan Medical Research
🇺🇸New York, New York, United States
LION Research
🇺🇸Norman, Oklahoma, United States
Erickson Research and Development
🇺🇸Clinton, Utah, United States
Lynn Institute of the Oz
🇺🇸Norman, Oklahoma, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
American Health Network of Indiana, LLC
🇺🇸Greenfield, Indiana, United States
Sante Clinical Research
🇺🇸Kerrville, Texas, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Center for Advanced Medical Research
🇺🇸Saint Peters, Missouri, United States
Saint Vincent's Medical Center (BRANY)
🇺🇸Gulf Shores, Alabama, United States
Arkansas Primary Care Clinic, PA
🇺🇸Little Rock, Arkansas, United States
International Research Associates, LLC
🇺🇸Hialeah, Florida, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Carteret Medical Group, LLC
🇺🇸Morehead City, North Carolina, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
University of Tennessee Health Sciences Center
🇺🇸Memphis, Tennessee, United States
Care Partners Clinical Research, LLC
🇺🇸Jacksonville, Florida, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Denver VA Medical Center
🇺🇸Denver, Colorado, United States
AMPM Research Clinic
🇺🇸Miami, Florida, United States
Epocrates Medical and Research Center
🇺🇸Miami, Florida, United States
Accent Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Palm Research Center, Inc.
🇺🇸Las Vegas, Nevada, United States
Novel Research of New York
🇺🇸Bronx, New York, United States
Juno Research, LLC
🇺🇸Houston, 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
Radiant Research
🇺🇸Saint Louis, Missouri, United States