STUDY OF MANAGEMENT OF PASIREOTIDE-INDUCED HYPERGLYCEMIA IN ADULT PATIENTS WITH CUSHING´S DISEASE OR ACROMEGALY
- Conditions
- -E240 Pituitary-dependent Cushing disease-E220 Acromegaly and pituitary gigantismAcromegaly and pituitary gigantismPituitary-dependent Cushing diseaseE220E240
- Registration Number
- PER-018-15
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 11
Cushing’s disease population
-Adult patients (age ≥ 18 y) with confirmed diagnosis of Cushing’s disease
(persistent/recurrent or de Novo patients who are not considered candidates
for pituitary surgery).
Acromegaly population
-Adult patients (age ≥ 18 y) with confirmed diagnosis of acromegaly. De Novo
patients (with no prior pituitary surgery) can be included if they are not considered candidates for pituitary surgery or have refused surgery.
Patients being treated at screening visit with pasireotide should have an elevated FPG > ULN or a diagnosis of diabetes during screening period.
-Patients who are receiving other medical therapies for Cushing’s disease or acromegaly. All other medical therapies for Cushing’s disease or acromegaly have to be discontinued at least 5 times the half-life of the respective preparation before study entry (start of pasireotide).
-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
-History of liver disease
-Cholelithiasis or acute or chronic pancreatitis
-Cardiac or repolarization abnormality
-Life-threatening autoimmune disorders
-Patients who have clinical symptoms of hypothyroidism
-Inadequate bone marrow function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method