Cushing's Disease | Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
Cushing's Disease research study
What is the primary objective of this 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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Pasireotide s.c.To be administered to Cushing's patients
Drug:SitagliptinTaken for 16 weeks or until the drug is found to be not effective
Drug:LiraglutidePatient will switch to liraglutide if sitagliptin is found to be inefficacious.
Drug:InsulinPatient will take insulin for 16 weeks.
Drug:Pasireotide LARTo be administered to acromegaly patients
Drug:MetforminIf 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 experience increases in their fasting blood glucose 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Incretin based therapyPatients randomized to the incretin based arm will start with sitagliptin once daily. If sitagliptin does not control the patient's hyperglycemia, sitagliptin will be stopped and patients will be switched to liraglutide once daily.
InsulinPatients randomized to the insulin arm may start with once daily dose of basal insulin. The dose may be up or down titrated at the discretion of the investigator. If blood glucose levels remain uncontrolled on basal insulin, patient may be switched to basal insulin plus prandial insulin.
Start Date: May 23, 2014
Completed Date: March 26, 2018
Phase: Phase 4
Primary Outcome: Change in HbA1c from randomization to approximately 16 weeks
Secondary Outcome: Change in HbA1c and FPG (Fasting Plasma Glucose) from randomization over time and to Core EOP (End of Phase) (only for FPG) per randomized arm
Study sponsors, principal investigator, and references
Principal Investigator: Novartis Pharmaceuticals
Lead Sponsor: Novartis Pharmaceuticals