Last updated on November 2018

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

Contact Investigators or Research Sites near you

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Raymond Fink

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

Novartis Pharmaceuticals

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

Ronald H. Chochinov

Coastal Metabolic Research Centre SC
Ventura, CA United States

Mae Sheikh-Ali

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

Julie Silverstein

Washington University SC - SOM230B2411
Saint Louis, MO United States

Barry Cohan

Great Falls Clinic Great Falls Clinic
Great Falls, MT United States

Sara Lubitz

Robert Wood Johnson Medical School - Rutgers SC
New Brunswick, NJ United States

Novartis Pharmaceuticals

University of New Mexico Clinical & Translational Science Ct
Albuquerque, NM United States

Eliza B. Geer

The Mount Sinai Hospital SC
New York, NY United States

Pamela U. Freda

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

John Boockvar

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

Murray B Gordon

Allegheny Endocrinology Associates SC
Pittsburgh, PA United States

Andrea L. Utz

Vanderbilt Clinical Trials Center SOM230B2219
Nashville, TN United States

Novartis Pharmaceuticals

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

James LaRocque

Virginia Endocrinology Research SC-2
Chesapeake, VA United States

Zachary Litvak

Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, WA United States

Novartis Pharmaceuticals

Novartis Investigative Site
Leuven, Belgium

Novartis Pharmaceuticals

Novartis Investigative Site
Wilrijk, Belgium

Novartis Pharmaceuticals

Novartis Investigative Site
Rio de Janeiro, Brazil

Novartis Pharmaceuticals

Novartis Investigative Site
Porto Alegre, Brazil

Novartis Pharmaceuticals

Novartis Investigative Site
Joinville, Brazil

Novartis Pharmaceuticals

Novartis Investigative Site
Beijing, China

Novartis Pharmaceuticals

Novartis Investigative Site
Chengdu, China

Novartis Pharmaceuticals

Novartis Investigative Site
Guangzhou, China

Novartis Pharmaceuticals

Novartis Investigative Site
Aalborg, Denmark

Novartis Pharmaceuticals

Novartis Investigative Site
Aarhus, Denmark

Novartis Pharmaceuticals

Novartis Investigative Site
Herlev, Denmark

Novartis Pharmaceuticals

Novartis Investigative Site
Odense C, Denmark

Novartis Pharmaceuticals

Novartis Investigative Site
Erlangen, Germany

Novartis Pharmaceuticals

Novartis Investigative Site
Freiburg, Germany

Novartis Pharmaceuticals

Novartis Investigative Site
Germering, Germany

Novartis Pharmaceuticals

Novartis Investigative Site
Oldenburg, Germany

Novartis Pharmaceuticals

Novartis Investigative Site
Bangalore, India

Novartis Pharmaceuticals

Novartis Investigative Site
Vellore, India

Novartis Pharmaceuticals

Novartis Investigative Site
San Isidro, Peru

Novartis Pharmaceuticals

Novartis Investigative Site
Warszawa, Poland

Novartis Pharmaceuticals

Novartis Investigative Site
Wroclaw, Poland

Novartis Pharmaceuticals

Novartis Investigative Site
Moscow, Russian Federation

Novartis Pharmaceuticals

Novartis Investigative Site
Saint Petersburg, Russian Federation

Novartis Pharmaceuticals

Novartis Investigative Site
Bangkok, Thailand

Novartis Pharmaceuticals

Novartis Investigative Site
Songkla, Thailand

Novartis Pharmaceuticals

Novartis Investigative Site
Altunizade, Turkey

Novartis Pharmaceuticals

Novartis Investigative Site
Ankara, Turkey

Novartis Pharmaceuticals

Novartis Investigative Site
Antalya, Turkey

Novartis Pharmaceuticals

Novartis Investigative Site
São Paulo, Brazil

Novartis Pharmaceuticals

Novartis Investigative Site
Copenhagen Ø, Denmark

Recruitment Status: Closed


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