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

Use our guide to learn which trials are right for you!

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
36
sites
Meridian, Idaho 83646
666
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1182
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
1281
mi
from 91732
Topeka, KS
Click here to add this to my saved trials
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...
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
1780
mi
from 91732
Avon, IN
Click here to add this to my saved trials
Birmingham, Alabama 35235
1792
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Bronx, New York 10461
2441
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
Brooksville, Florida
2126
mi
from 91732
Brooksville, FL
Click here to add this to my saved trials
Clinton, Utah 84015
586
mi
from 91732
Clinton, UT
Click here to add this to my saved trials
5337 Yorktown Boulevard
Corpus Christi, Texas 78413
1297
mi
from 91732
Corpus Christi, TX
Click here to add this to my saved trials
1223
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80220
821
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Franklin, Indiana 46131
1797
mi
from 91732
Franklin, IN
Click here to add this to my saved trials
Franklin, Ohio 45005
1960
mi
from 91732
Franklin, OH
Click here to add this to my saved trials
Greenfield, Indiana 46140
1813
mi
from 91732
Greenfield, IN
Click here to add this to my saved trials
Gulf Shores, Alabama 36542
1785
mi
from 91732
Gulf Shores, AL
Click here to add this to my saved trials
2313
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77074
1351
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32277
2133
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Kerrville, Texas 78028
1137
mi
from 91732
Kerrville, TX
Click here to add this to my saved trials
Las Vegas, Nevada 89102
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Las Vegas, Nevada 89106
217
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72204
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
1585
mi
from 91732
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33145
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2322
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Morehead City, North Carolina 28557
2337
mi
from 91732
Morehead City, NC
Click here to add this to my saved trials
New York, New York 10016
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
Norman, Oklahoma 73069
1168
mi
from 91732
Norman, OK
Click here to add this to my saved trials
Norman, Oklahoma 73069
1170
mi
from 91732
Norman, OK
Click here to add this to my saved trials
Ocoee, Florida 34761
2174
mi
from 91732
Ocoee, FL
Click here to add this to my saved trials
Saint Louis, Missouri 63151
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
Saint Peters, Missouri 63303
1554
mi
from 91732
Saint Peters, MO
Click here to add this to my saved trials
San Antonio, Texas 78228
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78229
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
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...
2540
mi
from 91732
Worcester, MA
Click here to add this to my saved trials