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

NCT02638805 | Completed Phase 3

• 1 other identifier: ITCA 650-CLP-201
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 36

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number (percentage) and severity of all treatment-emergent adverse events

  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

  from baseline to Week 26

Other Outcomes (3)

• Change from baseline in blood pressure and heart rate

  from baseline to 34 weeks

• Change from baseline in fasting plasma glucose

  from baseline to Week 26

• Change from baseline in cholesterol

  from baseline to Week 26

Study Arms (2)

Group 1

EXPERIMENTAL

ITCA 650 20/60 mcg/day

Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day; Drug: Metformin; Drug: Liraglutide

Group 2

EXPERIMENTAL

ITCA 650 60 mcg/day

Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day; Drug: Metformin; Drug: Liraglutide

Interventions

ITCA 650 Osmotic Mini Pump 20/60 mcg/day DRUG

ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day

Group 1

ITCA 650 Osmotic Mini Pump 60 mcg/day DRUG

ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day

Group 2

Metformin DRUG

Stable dose for at least 3 months (at least 1000 mg/day)

Group 1; Group 2

Liraglutide DRUG

Stable dose for at least 3 months (at least 1.2 mg/day)

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intarcia Therapeutics: lead

Study Sites (36)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Saint Vincent's Medical Center (BRANY)

Gulf Shores, Alabama, 36542, United States

Location

Arkansas Primary Care Clinic, PA

Little Rock, Arkansas, 72204, United States

Location

University of Colorado Hospital

Aurora, Colorado, United States

Location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Meridien Research

Brooksville, Florida, 34601, United States

Location

International Research Associates, LLC

Hialeah, Florida, 33012, United States

Location

Care Partners Clinical Research, LLC

Jacksonville, Florida, 32218, United States

Location

AMPM Research Clinic

Miami, Florida, 33145, United States

Location

Epocrates Medical and Research Center

Miami, Florida, 33175, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

American Health Network of Indiana, LLC

Avon, Indiana, 46123, United States

Location

American Health Network of Indiana, LLC

Franklin, Indiana, 46131, United States

Location

American Health Network of Indiana, LLC

Greenfield, Indiana, 46140, United States

Location

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Center for Advanced Medical Research

City of Saint Peters, Missouri, 63303, United States

Location

Radiant Research

St Louis, Missouri, 63141, United States

Location

Accent Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

Palm Research Center, Inc.

Las Vegas, Nevada, 89148, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Novel Research of New York

The Bronx, New York, 10461, United States

Location

Carteret Medical Group, LLC

Morehead City, North Carolina, 28557, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Lynn Institute of the Oz

Norman, Oklahoma, 73069, United States

Location

LION Research

Norman, Oklahoma, 73072, United States

Location

University of Tennessee Health Sciences Center

Memphis, Tennessee, 38103, United States

Location

Coastal Bend Clinical Research

Corpus Christi, Texas, 78414, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

Juno Research, LLC

Houston, Texas, 77036, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Panacea Clinical Research, LLC

San Antonio, Texas, 78228, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Victorium Clinical Research Ltd.

San Antonio, Texas, 78229, United States

Location

Erickson Research and Development

Clinton, Utah, 84015, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 23, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (36)