Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
Status:
Completed
Trial end date:
2018-03-26
Target enrollment:
Participant gender:
Summary
The study was designed to investigate the optimal management of hyperglycemia developed
during pasireotide treatment in participants with Cushing's disease or Acromegaly, which was
not manageable with metformin.
This was a Phase IV, multi-center, randomized, open-label study. Eligible patients started
pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting
release) for Acromegaly.
Participants being treated with pasireotide s.c or LAR at screening were eligible as long as
they met protocol criteria during the screening period. If previously normo-glycemic
participants experienced an increase in their fasting blood glucose and met the criteria for
diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they
continued to have elevated blood glucose above target on metformin within the first 16 weeks,
they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or
insulin for approximately 16 weeks.
Participants who continued to receive clinical benefit after completing the Core Phase could
enter an optional Extension Phase if pasireotide was not commercially available in their
country or a local access program was not available to provide drug. Patients continued in
the Extension Phase until the last participant randomized in the Core Phase completed 16
weeks of treatment post-randomization.