Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

This is a Phase IV, multi-center, randomized, open-label study. Eligible patients will start
pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting
release) for acromegaly. Patients currently treated at screening visit with pasireotide s.c.
or LAR are eligible as long as they meet protocol criteria during the screening period. If
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 have elevated blood sugars above target on
metformin 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.

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.