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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:11/7/2018
Start Date:December 2015
End Date:October 2017

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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.


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.
We found this trial at
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Denver, Colorado 80220
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Birmingham, Alabama 35235
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Bronx, New York 10461
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Clinton, Utah 84015
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5337 Yorktown Boulevard
Corpus Christi, Texas 78413
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Gulf Shores, Alabama 36542
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Houston, Texas 77074
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Jacksonville, Florida 32277
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Kerrville, Texas 78028
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Las Vegas, Nevada 89102
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Little Rock, Arkansas 72204
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Meridian, Idaho 83646
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Miami, Florida 33145
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Morehead City, North Carolina 28557
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New York, New York 10016
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Norman, Oklahoma 73069
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Norman, Oklahoma 73069
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Ocoee, Florida 34761
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Saint Louis, Missouri 63151
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Saint Peters, Missouri 63303
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San Antonio, Texas 78228
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San Antonio, Texas 78229
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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