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Spots Global Cancer Trial Database for Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

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Trial Identification

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

Official Title: A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly

Study ID: NCT02060383

Study Description

Brief Summary: The study was designed to investigate the optimal management of hyperglycemia developed during pasireotide treatment in participants with Cushing's disease or Acromegaly, which was not manageable with metformin. This was a Phase IV, multi-center, randomized, open-label study. Eligible patients started pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for Acromegaly. Participants being treated with pasireotide s.c or LAR at screening were eligible as long as they met protocol criteria during the screening period. If previously normo-glycemic participants experienced an increase in their fasting blood glucose and met the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to have elevated blood glucose above target on metformin within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks. Participants who continued to receive clinical benefit after completing the Core Phase could enter an optional Extension Phase if pasireotide was not commercially available in their country or a local access program was not available to provide drug. Patients continued in the Extension Phase until the last participant randomized in the Core Phase completed 16 weeks of treatment post-randomization.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

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

Coastal Metabolic Research Centre SC, Ventura, California, United States

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

Washington University SC - SOM230B2411, Saint Louis, Missouri, United States

Great Falls Clinic, Great Falls, Montana, United States

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

The Mount Sinai Hospital SC, New York, New York, United States

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

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

Allegheny Endocrinology Associates SC, Pittsburgh, Pennsylvania, United States

Vanderbilt Clinical Trials Center SOM230B2219, Nashville, Tennessee, United States

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

Virginia Endocrinology Research SC-2, Chesapeake, Virginia, United States

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

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Wilrijk, , Belgium

Novartis Investigative Site, Rio de Janeiro, RJ, Brazil

Novartis Investigative Site, Porto Alegre, RS, Brazil

Novartis Investigative Site, Joinville, SC, Brazil

Novartis Investigative Site, São Paulo, SP, Brazil

Novartis Investigative Site, Beijing, Beijing, China

Novartis Investigative Site, Guangzhou, Guangdong, China

Novartis Investigative Site, Chengdu, Sichuan, China

Novartis Investigative Site, Aalborg, , Denmark

Novartis Investigative Site, Aarhus, , Denmark

Novartis Investigative Site, Herlev, , Denmark

Novartis Investigative Site, Odense C, , Denmark

Novartis Investigative Site, Erlangen, , Germany

Novartis Investigative Site, Freiburg, , Germany

Novartis Investigative Site, Oldenburg, , Germany

Novartis Investigative Site, Bangalore, Karnataka, India

Novartis Investigative Site, Vellore, Tamil Nadu, India

Novartis Investigative Site, San Isidro, Lima, Peru

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Wroclaw, , Poland

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Bangkok, , Thailand

Novartis Investigative Site, Songkla, , Thailand

Novartis Investigative Site, Altunizade, , Turkey

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Antalya, , Turkey

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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