STUDY OF MANAGEMENT OF PASIREOTIDE-INDUCED HYPERGLYCEMIA IN ADULT PATIENTS WITH CUSHING´S DISEASE OR ACROMEGALY

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-018-15

Enrollment

Registered

2015-09-21

Start date

2015-07-06

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug: Pasireotide s.c. To be administered to Cushing´s patients Drug: Sitagliptin Taken for 16 weeks or until the drug is found to be not effective Drug: Liraglutide Patient will switch

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: -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

Countries

Belgium, Brazil, China, Denmark, France, Germany, India, Italy, Netherlands, Peru, Poland, Russian Federation, Taiwan, Thailand, Turkey

Contacts

Public ContactJoel Sachun

NOVARTIS BIOSCIENCES PERU S.A.

joel.sachun@novartis.com2006516

Outcome results