Last updated on October 2017

Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly


Brief description of study

The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and safely managed in majority of patients, including those with diabetes at start of pasireotide treatment.

Detailed Study Description

This is a Phase IV, multi-center, randomized, open-label study. Eligible patients will start pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for acromegaly. Patients currently treated at screening visit with pasireotide s.c. or LAR are eligible as long as they meet protocol criteria during the screening period. If previously normo-glycemic patients experience increases in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they will start anti-diabetic treatment using metformin. If they continue to have elevated blood sugars above target on metformin within the first 16 weeks, they will be randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.

Clinical Study Identifier: NCT02060383

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Raymond Fink

Diabetes and Endocrine Associates La Mesa Location
Multiple Locations, CA United States
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Ronald Swerdloff

LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219
Torrance, CA United States
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Ronald H. Chochinov

Coastal Metabolic Research Centre SC
Ventura, CA United States
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Mae Sheikh-Ali

East Coast Institute for Research East Coast Inst. for Res(ECIR)
Jacksonville, FL United States
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Julie Silverstein

Washington University SC - SOM230B2411
Saint Louis, MO United States
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Barry Cohan

Great Falls Clinic Great Falls Clinic
Great Falls, MT United States
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Sara Lubitz

Robert Wood Johnson Medical School - Rutgers SC
New Brunswick, NJ United States
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University of New Mexico Clinical & Translational Science Ct
Albuquerque, NM United States
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Eliza B. Geer

The Mount Sinai Hospital SC
New York, NY United States
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Pamela U. Freda

Columbia University Medical Center- New York Presbyterian Neuroendocrine Unit
New York, NY United States
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John Boockvar

Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC
New York, NY United States
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Murray B Gordon

Allegheny Endocrinology Associates SC
Pittsburgh, PA United States
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Andrea L. Utz

Vanderbilt Clinical Trials Center SOM230B2219
Nashville, TN United States
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Susan L. Samson

Baylor College of Medicine Ben Taub General Hosp.
Houston, TX United States
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James LaRocque

Virginia Endocrinology Research SC-2
Chesapeake, VA United States
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Zachary Litvak

Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, WA United States
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Leuven, Belgium
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Wilrijk, Belgium
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Chengdu, China
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Aalborg, Denmark
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Aarhus, Denmark
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Copenhagen Ø, Denmark
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Herlev, Denmark
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Odense C, Denmark
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Erlangen, Germany
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Freiburg, Germany
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Germering, Germany
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Oldenburg, Germany
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Bangalore, India
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Vellore, India
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San Isidro, Peru
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Warszawa, Poland
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Wroclaw, Poland
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Moscow, Russian Federation
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Songkla, Thailand
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Altunizade, Turkey
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Ankara, Turkey
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Antalya, Turkey
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