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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR