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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638805
• Other study ID #: ITCA 650-CLP-201
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: October 2017

Study information

• Verified date: November 2018
• Source: Intarcia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	American Health Network of Indiana, LLC	Avon	Indiana
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Novel Research of New York	Bronx	New York
United States	Meridien Research	Brooksville	Florida
United States	Erickson Research and Development	Clinton	Utah
United States	Coastal Bend Clinical Research	Corpus Christi	Texas
United States	Dallas Diabetes and Endocrine Center	Dallas	Texas
United States	Denver VA Medical Center	Denver	Colorado
United States	American Health Network of Indiana, LLC	Franklin	Indiana
United States	Prestige Clinical Research	Franklin	Ohio
United States	American Health Network of Indiana, LLC	Greenfield	Indiana
United States	Saint Vincent's Medical Center (BRANY)	Gulf Shores	Alabama
United States	International Research Associates, LLC	Hialeah	Florida
United States	Juno Research, LLC	Houston	Texas
United States	Care Partners Clinical Research, LLC	Jacksonville	Florida
United States	Sante Clinical Research	Kerrville	Texas
United States	Accent Clinical Trials	Las Vegas	Nevada
United States	Palm Research Center, Inc.	Las Vegas	Nevada
United States	Arkansas Primary Care Clinic, PA	Little Rock	Arkansas
United States	University of Tennessee Health Sciences Center	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	AMPM Research Clinic	Miami	Florida
United States	Epocrates Medical and Research Center	Miami	Florida
United States	Carteret Medical Group, LLC	Morehead City	North Carolina
United States	Manhattan Medical Research	New York	New York
United States	LION Research	Norman	Oklahoma
United States	Lynn Institute of the Oz	Norman	Oklahoma
United States	Sensible Healthcare, LLC	Ocoee	Florida
United States	Radiant Research	Saint Louis	Missouri
United States	Center for Advanced Medical Research	Saint Peters	Missouri
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Panacea Clinical Research, LLC	San Antonio	Texas
United States	Victorium Clinical Research Ltd.	San Antonio	Texas
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Intarcia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change from baseline in fasting plasma glucose		from baseline to Week 26
Other	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
Primary	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	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
Secondary	Incidence of hypoglycemia		From Randomization to 34 weeks
Secondary	Change in percentage of glycosylated hemoglobin (HbA1c) in the blood		From baseline to Week 26
Secondary	Change in body weight	Change from baseline in body weight at Week 26	from baseline to Week 26