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Study identifier: NCT02638805 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Completed

Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

Condition: Diabetes Mellitus, Type 2  ·  Sponsor: Intarcia Therapeutics

PhasePhase 3
Planned participants136
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where36 locations
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.Open the site landscape →

About this study

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (36)

Alabama Clinical Therapeutics, LLCBirmingham, Alabama, United States
Saint Vincent's Medical Center (BRANY)Gulf Shores, Alabama, United States
Arkansas Primary Care Clinic, PALittle Rock, Arkansas, United States
University of Colorado HospitalAurora, Colorado, United States
Denver VA Medical CenterDenver, Colorado, United States
Meridien ResearchBrooksville, Florida, United States
International Research Associates, LLCHialeah, Florida, United States
Care Partners Clinical Research, LLCJacksonville, Florida, United States
AMPM Research ClinicMiami, Florida, United States
Epocrates Medical and Research CenterMiami, Florida, United States
Sensible Healthcare, LLCOcoee, Florida, United States
Solaris Clinical ResearchMeridian, Idaho, United States

+ 24 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BirminghamGulf ShoresLittle RockAurora

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