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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day; Drug: Metformin; Drug: Liraglutide; Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Gulf Shores, Alabama, United States, 36542
      • Saint Vincent's Medical Center (BRANY)
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Arkansas Primary Care Clinic, PA
  • Colorado
    • Aurora, Colorado, United States
      • University of Colorado Hospital
    • Denver, Colorado, United States, 80220
      • Denver VA Medical Center
  • Florida
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Hialeah, Florida, United States, 33012
      • International Research Associates, LLC
    • Jacksonville, Florida, United States, 32218
      • Care Partners Clinical Research, Llc
    • Miami, Florida, United States, 33145
      • AMPM Research Clinic
    • Miami, Florida, United States, 33175
      • Epocrates Medical and Research Center
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare, LLC
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana, LLC
    • Franklin, Indiana, United States, 46131
      • American Health Network of Indiana, LLC
    • Greenfield, Indiana, United States, 46140
      • American Health Network of Indiana, LLC
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Radiant Research
    • Saint Peters, Missouri, United States, 63303
      • Center for Advanced Medical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center, Inc.
    • Las Vegas, Nevada, United States, 89119
      • Accent Clinical Trials
  • New York
    • Bronx, New York, United States, 10461
      • Novel Research of New York
    • New York, New York, United States, 10016
      • Manhattan Medical Research
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group, LLC
  • Ohio
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Lynn Institute of the Oz
    • Norman, Oklahoma, United States, 73072
      • Lion Research
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Sciences Center
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Coastal Bend Clinical Research
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes and Endocrine Center
    • Houston, Texas, United States, 77036
      • Juno Research, LLC
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78228
      • Panacea Clinical Research, LLC
    • San Antonio, Texas, United States, 78229
      • Victorium Clinical Research Ltd.
  • Utah
    • Clinton, Utah, United States, 84015
      • Erickson Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; ITCA 650 20/60 mcg/day	Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day; ITCA 650 osmotic mini pump delivering exenatide 20/60 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)
Experimental: Group 2; ITCA 650 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); Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day; ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting	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.	From Randomization to 34 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (percentage) and severity of all treatment-emergent adverse events	All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide	From Randomization to 34 weeks
Incidence of hypoglycemia		From Randomization to 34 weeks
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood		From baseline to Week 26
Change in body weight	Change from baseline in body weight at Week 26	from baseline to Week 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in blood pressure and heart rate	Change from baseline in blood pressure and heart rate at Week 26	from baseline to 34 weeks
Change from baseline in fasting plasma glucose		from baseline to Week 26
Change from baseline in cholesterol	Change in low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)	from baseline to Week 26

Collaborators and Investigators

• Sponsor: Intarcia Therapeutics

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Liraglutide; Metformin; Exenatide
• Other Study ID Numbers: ITCA 650-CLP-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No