A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:3/9/2019
Start Date:May 2013
End Date:January 2018

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An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients
with initial HbA1c >10% by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment
with ITCA 650 60 mcg/day


Inclusion Criteria:

- Men or women age 18 to 80 years with type 2 diabetes

- On stable treatment regimen of diet and exercise alone or in combination with a stable
& optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these
drugs

- HbA1c >10.0% and ≤12.0%

Exclusion Criteria:

- Prior treatment with any GLP-1 receptor agonist

- History of hypersensitivity to exenatide or liraglutide

- FPG >300 mg/dL

- History of medullary thyroid cancer or a family or personal history of multiple
endocrine neoplasia type 2

- Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides
or insulin within last 3 months

- history of pancreatitis
We found this trial at
50
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99 N. Brice Rd
Columbus, Ohio 43068
614-501-6164
1970
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Columbus, OH
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
2134
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Jacksonville, FL
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Ste 205, 10796 Pines Boulevard
Pembroke Pines, Florida 33026
2310
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9 Dunwoody Park
Atlanta, Georgia 30338
1921
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Austin, Texas 78745
1212
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Avon, IN
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Birmingham, Alabama 35235
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Birmingham, AL
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Bradenton, Florida
2140
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Bradenton, FL
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Chandler, Arizona 85224
356
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Chandler, AZ
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Charlotte, North Carolina 28209
2101
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Charlotte, NC
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Chicago, Illinois 60634
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Chicago, IL
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Chula Vista, California 91911
115
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Chula Vista, CA
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1880
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Cincinnati, OH
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2405 Research Parkway
Colorado Springs, Colorado 80920
807
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Corpus Christi, Texas 78414
1293
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Dallas, Texas 75251
1223
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
1225
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1223
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Durham, North Carolina 27713
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Evansville, Indiana 47714
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Evansville, IN
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Franklin, Indiana 46131
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Franklin, Ohio 45005
1960
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1350 O Street
Fresno, California 93721
209
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2029
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Greer, SC
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Gulf Shores, Alabama 36542
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1343
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Houston, TX
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Long Beach, California 90807
19
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Memphis, Tennessee 38119
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Meridian, Idaho 83646
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Meridian, ID
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Mesa, Arizona 85201
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Metairie, Louisiana 70006
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Miami, Florida 33175
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8200 Southwest 117th Avenue
Miami, Florida 33183
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Muncie, IN
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Norman, Oklahoma 73069
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North Miami Beach, Florida 33162
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Palm Harbor, Florida 34684
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Phoenix, Arizona 85282
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Port Hueneme, California 93041
67
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463 Tremont Street West
Port Orchard, Washington 98366
960
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Renton, Washington 98057
952
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Salisbury, North Carolina 28144
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7940 Floyd Curl Drive
San Angelo, Texas 78229
1182
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5115 North Armenia Avenue
Tampa, Florida 33603
2133
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2492 Walnut Avenue
Tustin, California 92780
27
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Uniontown, Pennsylvania 15401
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55 University Drive
Valparaiso, Indiana 46383
1756
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Walnut creek, California 94598
347
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
2126
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Winston-Salem, NC
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