Clinical trial NCT02638805: Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
Official title: An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-12-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
timeFrame: From Randomization to 34 weeks
Secondary outcomes:
measure: Number (percentage) and severity of all treatment-emergent adverse events
timeFrame: From Randomization to 34 weeks
measure: Incidence of hypoglycemia
timeFrame: From Randomization to 34 weeks
measure: Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
timeFrame: From baseline to Week 26
measure: Change in body weight
timeFrame: from baseline to Week 26
Other outcomes:
measure: Change from baseline in blood pressure and heart rate
timeFrame: from baseline to 34 weeks
measure: Change from baseline in fasting plasma glucose
timeFrame: from baseline to Week 26
measure: Change from baseline in cholesterol
timeFrame: from baseline to Week 26
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Gulf Shores
country: United States
facility: Saint Vincent's Medical Center (BRANY)
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic, PA
state: Arkansas
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Hialeah
country: United States
facility: International Research Associates, LLC
state: Florida
city: Jacksonville
country: United States
facility: Care Partners Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: AMPM Research Clinic
state: Florida
city: Miami
country: United States
facility: Epocrates Medical and Research Center
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC
state: Florida
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Avon
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Franklin
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Greenfield
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Saint Peters
country: United States
facility: Center for Advanced Medical Research
state: Missouri
city: Las Vegas
country: United States
facility: Accent Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center, Inc.
state: Nevada
city: Bronx
country: United States
facility: Novel Research of New York
state: New York
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group, LLC
state: North Carolina
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of the Oz
state: Oklahoma
city: Norman
country: United States
facility: LION Research
state: Oklahoma
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Coastal Bend Clinical Research
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Panacea Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research Ltd.
state: Texas
city: Clinton
country: United States
facility: Erickson Research and Development
state: Utah
Study officials:
References: