249
Participants
Start Date
May 23, 2014
Primary Completion Date
February 5, 2018
Study Completion Date
March 26, 2018
Pasireotide s.c.
Administered to Cushing's disease participants.
Sitagliptin
Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective
Liraglutide
Participant switched to liraglutide if sitagliptin was found not to be effective.
Insulin
"Participant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required.~Insulin was administered to the BL-insulin group at the discretion of the Principal Investigator.~Note: OAD and No OAD groups within the non-randomized arm did not take Insulin."
Pasireotide LAR
Administered to Acromegaly participants.
Metformin
"If previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose 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. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator.~Note: No OAD group within the non-randomized arm did not take metformin."
Novartis Investigative Site, San Isidro
Novartis Investigative Site, Wilrijk
Novartis Investigative Site, Leuven
Novartis Investigative Site, Aalborg
The Mount Sinai Hospital SC, New York
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit, New York
Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC, New York
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok
Allegheny Endocrinology Associates SC, Pittsburgh
Virginia Endocrinology Research SC-2, Chesapeake
Novartis Investigative Site, Oldenburg
East Coast Institute for Research East Coast Inst. for Res(ECIR), Jacksonville
Novartis Investigative Site, Altunizade
Great Falls Clinic, Great Falls
Washington University SC - SOM230B2411, St Louis
Baylor College of Medicine Ben Taub General Hosp., Houston
Novartis Investigative Site, Freiburg im Breisgau
Novartis Investigative Site, Songkhla
LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219, Torrance
Novartis Investigative Site, Erlangen
Coastal Metabolic Research Centre SC, Ventura
Novartis Investigative Site, Beijing
Novartis Investigative Site, Saint Petersburg
Novartis Investigative Site, Guangzhou
Novartis Investigative Site, Bangalore
Novartis Investigative Site, Chengdu
Novartis Investigative Site, Vellore
Novartis Investigative Site, Joinville
Diabetes and Endocrine Associates La Mesa Location, Multiple Locations
Robert Wood Johnson Medical School - Rutgers SC, New Brunswick
Vanderbilt Clinical Trials Center SOM230B2219, Nashville
Swedish Medical Center Dept.ofSeattle Neuroscience(2), Seattle
Novartis Investigative Site, Rio de Janeiro
Novartis Investigative Site, Porto Alegre
Novartis Investigative Site, São Paulo
Novartis Investigative Site, Aarhus
Novartis Investigative Site, Herlev
Novartis Investigative Site, Odense C
Novartis Investigative Site, Warsaw
Novartis Investigative Site, Wroclaw
Novartis Investigative Site, Ankara
Novartis Investigative Site, Antalya
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY