Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:3/9/2019
Start Date:March 3, 2017
End Date:January 26, 2018

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A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of
ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in
patients with Type 2 diabetes.


Inclusion Criteria:

- Diagnosis of T2D 3 months prior to the Screening Visit.

- Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.

- Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior
to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).

Exclusion Criteria:

- History of type 1 diabetes.

- Prior participation in a clinical study involving ITCA 650.

- Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months
prior to Screening.

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

- Treatment of medications that affect GI motility.

- History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of
its excipients.

- Women that are pregnant, lactating, or planning to become pregnant.

- Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks
prior to screening.
We found this trial at
96
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Springfield, Illinois 62711
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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Los Angeles, CA
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Ste 205, 10796 Pines Boulevard
Pembroke Pines, Florida 33026
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Pembroke Pines, Florida 33027
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1779
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
2238
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
1454
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Topeka, KS
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Akron, Ohio 44311
2042
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Akron, OH
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
2353
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Albany, NY
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
980
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1879
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Anderson, IN
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Atlanta, Georgia 30312
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Atlanta, GA
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Auburn, Maine 04210
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Augusta, Kansas 67010
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1055 Clermont Street
Aurora, Colorado 80045
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1770
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Austin, TX
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
2031
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Belton, Missouri 64012
1516
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Belton, MO
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
2485
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Boston, MA
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Butte, Montana 59701
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Carlsbad, California 92008
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Centennial, Colorado 75115
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Charlotte, North Carolina 28207
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Chicago, Illinois 60604
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Cincinnati, OH
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Clinton, Utah 84015
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6340 Barnes Road
Colorado Springs, Colorado 80922
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5969 East Broad Street
Columbus, Ohio 43213
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Columbus, Ohio 43213
2014
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6122 West Corporate Oaks Drive
Crystal River, Florida 34429
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Dallas, Texas 75231
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Edina, Minnesota 55435
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Elkhorn, Nebraska 68022
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Evansville, Indiana 47714
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16838 East Palisades Boulevard
Fountain Hills, Arizona 85268
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Franklin, Indiana 46131
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Franklin, Ohio 45005
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Fresno, California 93726
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Glendale, Arizona 85308
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Greenbrae, California 94904
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Greensboro, North Carolina 27408
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Harleysville, Pennsylvania 19438
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Hazelwood, Missouri 63042
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Henderson, Nevada 89074
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Houston, Texas 77074
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2312 Tidwell Road
Houston, Texas 77093
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Huntington Park, California 90255
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Jacksonville, Florida 32216
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Kerrville, Texas 78028
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Kettering, Ohio 45429
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Kingsport, Tennessee 37660
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Las Vegas, Nevada 89102
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232-01 Merrick Boulevard
Laurelton, New York 11413
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Littleton, Colorado 80128
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Miami, Florida 33173
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Morehead City, North Carolina 28557
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New Albany, Indiana 47150
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1010 24th Avenue Northwest
Norman, Oklahoma 73069
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701 Northeast 10th Street
Oklahoma City, Oklahoma 73104
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Orlando, Florida 32806
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11725 West 112th Street
Overland Park, Kansas 66210
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Palm Harbor, Florida 34684
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111 S 11th St
Philadelphia, Pennsylvania 19107
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1050 Bower Hill Road
Pittsburgh, Pennsylvania 15243
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463 Tremont Street West
Port Orchard, Washington 98366
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3947 50A Avenue
Red Deer, Alberta T4N 6V7
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Rock Hill, South Carolina 29732
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Sacramento, California 95823
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3555 Knickerbocker Road
San Angelo, Texas 78228
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9969 Fredericksburg Road
San Antonio, Texas 78240
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4905 Old Orchard Road
Skokie, Illinois 60077
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Tempe, Arizona 85283
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
University of Toledo The University of Toledo is one of 14 state universities in Ohio....
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Tucson, Arizona 85712
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Tucson, Arizona 85741
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Uniontown, Pennsylvania 15401
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West Jordan, Utah 84088
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
2455
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