Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGITCA 650 Osmotic Mini Pump 20/60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
DRUGITCA 650 Osmotic Mini Pump 60 mcg/day
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
DRUGMetformin
Stable dose for at least 3 months (at least 1000 mg/day)
DRUGLiraglutide
Stable dose for at least 3 months (at least 1.2 mg/day)
Sponsors
Intarcia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in cholesterol | from baseline to Week 26 | Change in low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) |
| Change from baseline in fasting plasma glucose | from baseline to Week 26 | — |
| Change from baseline in blood pressure and heart rate | from baseline to 34 weeks | Change from baseline in blood pressure and heart rate at Week 26 |
Countries
United States
Outcome results
None listed