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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2017

Interventions

  • Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day
    • ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
  • Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day
    • ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
  • Drug: Metformin
    • Stable dose for at least 3 months (at least 1000 mg/day)
  • Drug: Liraglutide
    • Stable dose for at least 3 months (at least 1.2 mg/day)

Arms, Groups and Cohorts

  • Experimental: Group 1
    • ITCA 650 20/60 mcg/day
  • Experimental: Group 2
    • ITCA 650 60 mcg/day

Clinical Trial Outcome Measures

Primary Measures

  • Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
    • Time Frame: 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 Measures

  • Number (percentage) and severity of all treatment-emergent adverse events
    • Time Frame: 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
  • Incidence of hypoglycemia
    • Time Frame: From Randomization to 34 weeks
  • Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
    • Time Frame: From baseline to Week 26
  • Change in body weight
    • Time Frame: from baseline to Week 26
    • Change from baseline in body weight at Week 26

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intarcia Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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