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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITCA 650 Osmotic Mini Pump 20/60 mcg/day
ITCA 650 Osmotic Mini Pump 60 mcg/day
Metformin
Liraglutide
Sponsored by
Intarcia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Clinical Therapeutics, LLC
  • Saint Vincent's Medical Center (BRANY)
  • Arkansas Primary Care Clinic, PA
  • University of Colorado Hospital
  • Denver VA Medical Center
  • Meridien Research
  • International Research Associates, LLC
  • Care Partners Clinical Research, LLC
  • AMPM Research Clinic
  • Epocrates Medical and Research Center
  • Sensible Healthcare, LLC
  • Solaris Clinical Research
  • American Health Network of Indiana, LLC
  • American Health Network of Indiana, LLC
  • American Health Network of Indiana, LLC
  • Cotton-O'Neil Clinical Research Center
  • University of Massachusetts Medical School
  • Radiant Research
  • Center for Advanced Medical Research
  • Accent Clinical Trials
  • Palm Research Center, Inc.
  • Novel Research of New York
  • Manhattan Medical Research
  • Carteret Medical Group, LLC
  • Prestige Clinical Research
  • Lynn Institute of the Oz
  • LION Research
  • University of Tennessee Health Sciences Center
  • Coastal Bend Clinical Research
  • Dallas Diabetes and Endocrine Center
  • Juno Research, LLC
  • Sante Clinical Research
  • Panacea Clinical Research, LLC
  • Clinical Trials of Texas, Inc.
  • Victorium Clinical Research Ltd.
  • Erickson Research and Development

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

ITCA 650 20/60 mcg/day

ITCA 650 60 mcg/day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Incidence of hypoglycemia
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
Change in body weight
Change from baseline in body weight at Week 26

Full Information

First Posted
December 18, 2015
Last Updated
November 1, 2018
Sponsor
Intarcia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02638805
Brief Title
Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intarcia Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
ITCA 650 20/60 mcg/day
Arm Title
Group 2
Arm Type
Experimental
Arm Description
ITCA 650 60 mcg/day
Intervention Type
Drug
Intervention Name(s)
ITCA 650 Osmotic Mini Pump 20/60 mcg/day
Intervention Description
ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
Intervention Type
Drug
Intervention Name(s)
ITCA 650 Osmotic Mini Pump 60 mcg/day
Intervention Description
ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Stable dose for at least 3 months (at least 1000 mg/day)
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
Stable dose for at least 3 months (at least 1.2 mg/day)
Primary Outcome Measure Information:
Title
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
Description
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.
Time Frame
From Randomization to 34 weeks
Secondary Outcome Measure Information:
Title
Number (percentage) and severity of all treatment-emergent adverse events
Description
All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide
Time Frame
From Randomization to 34 weeks
Title
Incidence of hypoglycemia
Time Frame
From Randomization to 34 weeks
Title
Change in percentage of glycosylated hemoglobin (HbA1c) in the blood
Time Frame
From baseline to Week 26
Title
Change in body weight
Description
Change from baseline in body weight at Week 26
Time Frame
from baseline to Week 26
Other Pre-specified Outcome Measures:
Title
Change from baseline in blood pressure and heart rate
Description
Change from baseline in blood pressure and heart rate at Week 26
Time Frame
from baseline to 34 weeks
Title
Change from baseline in fasting plasma glucose
Time Frame
from baseline to Week 26
Title
Change from baseline in cholesterol
Description
Change in low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
Time Frame
from baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Saint Vincent's Medical Center (BRANY)
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Arkansas Primary Care Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
International Research Associates, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Care Partners Clinical Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32218
Country
United States
Facility Name
AMPM Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Epocrates Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Radiant Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Center for Advanced Medical Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Accent Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Novel Research of New York
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Manhattan Medical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Carteret Medical Group, LLC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Lynn Institute of the Oz
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
LION Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
University of Tennessee Health Sciences Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Coastal Bend Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Sante Clinical Research
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Panacea Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Victorium Clinical Research Ltd.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Erickson Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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