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
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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
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Akron, Ohio 44311
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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...
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1085 N Harbor Blvd
Anaheim, California 92801
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Anderson, IN
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Atlanta, Georgia 30312
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811 Juniper St NE
Atlanta, Georgia 30308
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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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6400 Perkins Rd
Baton Rouge, Louisiana 70808
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Belton, Missouri 64012
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One Joslin Place
Boston, Massachusetts 02215
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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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Columbus, Ohio 43213
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Columbus, Ohio 43213
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Crystal River, Florida 34429
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Fountain Hills, Arizona 85268
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Harleysville, Pennsylvania 19438
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Houston, Texas 77093
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Huntington Park, California 90255
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3555 NW 58th St # 800
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Philadelphia, Pennsylvania 19107
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Port Orchard, Washington 98366
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Red Deer, Alberta T4N 6V7
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San Antonio, Texas 78240
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2801 W. Bancroft
Toledo, Ohio 43606
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1907 Tradd Ct
Wilmington, North Carolina 28401
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