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
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.
Change in HbA1c From Randomization to Approximately 16 Weeks
Change in HbA1c From Randomization (R) Over Time Per Randomized Arm
Study Arms / Comparison Groups
Incretin based therapy (randomized group)
Description: Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
May 23, 2014
March 26, 2018
Primary Completion Date
February 5, 2018
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.
18 Years - N/A
Accepts Healthy Volunteers
Novartis Pharmaceuticals, ,
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals