Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
Cushing's Disease, Acromegaly
About this trial
This is an interventional supportive care trial for Cushing's Disease focused on measuring Cushing's disease, acromegaly, pasireotide, hyperglycemia
Eligibility Criteria
Inclusion Criteria:
- Patients greater than or equal to 18 years old
- Confirmed diagnosis of Cushing's disease or acromegaly
Exclusion Criteria:
- Patients who require surgical intervention
- Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry
- HbA1c > 10 % at screening
- Known hypersensitivity to somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Diabetes and Endocrine Associates La Mesa Location
- LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219
- Coastal Metabolic Research Centre SC
- East Coast Institute for Research East Coast Inst. for Res(ECIR)
- Washington University SC - SOM230B2411
- Great Falls Clinic
- Robert Wood Johnson Medical School - Rutgers SC
- The Mount Sinai Hospital SC
- Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
- Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC
- Allegheny Endocrinology Associates SC
- Vanderbilt Clinical Trials Center SOM230B2219
- Baylor College of Medicine Ben Taub General Hosp.
- Virginia Endocrinology Research SC-2
- Swedish Medical Center Dept.ofSeattle Neuroscience(2)
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
Incretin based therapy (randomized group)
Insulin (randomized group)
Non-Randomized Arm
Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin.
Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin.
This arm represents the non-randomized participants: Cushing's Disease (CD) or Acromegaly participants, who received pasireotide s.c. or LAR (long-acting release) respectively, but who were not randomized to the Incretin or Insulin arms. For the purpose of analysis, this non-randomized arm is further split into 3 groups: Baseline insulin group (BL insulin) includes participants who were receiving insulin at study entry Oral antidiabetic drugs (OAD) group includes participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment No OAD group includes participants who did not receive any anti-diabetic medication during the core phase of the trial