Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:6/27/2018
Start Date:September 2015
End Date:May 11, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin

The purpose of this study is to evaluate the efficacy, safety, and tolerability of
ISIS-GCGRRx in combination with metformin versus placebo


Inclusion Criteria:

- Male or female, age 18 to 75

- BMI ≥ 25.0 kg/m2

- HbA1c ≥ 8.0% and ≤ 10.5%

- Type 2 Diabetes Mellitus and on stable dose of Metformin

- Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

- Clinically significant abnormalities in medical history of physical exam

- Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results

- History of solid organ transplant or renal dialysis

- History of liver disease

- History of greater than 3 episodes of severe hypoglycemia within 6 months of screening

- Treatment with any other antidiabetic drug(s) other than metformin within 3 months of
screening

- History of diabetic ketoacidosis

- Any other significant illness or condition that may interfere with the patient
participating or completing the study

- Inability or unwillingness to comply with protocol or study procedures
We found this trial at
19
sites
Ionis Investigational Site
Katy, Texas 77450
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Katy, TX
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IONIS Investigative Site
Cincinnati, Ohio 45227
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Cincinnati, OH
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IONIS Investigative Site
Cincinnati, Ohio 45227
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Cincinnati, OH
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Ionis Investigational Site
Eugene, Oregon 97404
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Eugene, OR
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Ionis Investigational Site
Greenbrae, California 94904
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Greenbrae, CA
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Ionis Investigational Site
Greensboro, North Carolina 27410
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Greensboro, NC
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IONIS Investigative Site
Houston, Texas 77030
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Houston, TX
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IONIS Investigative Site
Houston, Texas 77030
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Houston, TX
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Ionis Investigational Site
Huntington Park, California 90255
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Huntington Park, CA
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Ionis Investigational Site
La Mesa, California 91942
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La Mesa, CA
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Ionis Investigational Site
Los Angeles, California 90057
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Los Angeles, CA
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Ionis Investigational Site
Marietta, Georgia 30060
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Marietta, GA
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Ionis Investigational Site
Morehead City, North Carolina 28557
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Morehead City, NC
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Ionis Investigational Site
New York, New York 10016
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New York, NY
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Ionis Investigational Site
Olympia, Washington 98502
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Olympia, WA
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Ionis Investigational Site
Oxon Hill, Maryland 20745
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Oxon Hill, MD
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Ionis Investigational Site
Port Orange, Florida 32127
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Port Orange, FL
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Ionis Investigational Site
Spartanburg, South Carolina 29303
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Spartanburg, SC
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Isis Investigational Site
Spring Valley, California 91978
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Spring Valley, CA
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