NCT02060383

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: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cushing's Disease
• Acromegaly

Interventions

Type	Name	Description
DRUG	Pasireotide s.c.	Administered to Cushing's disease participants.
DRUG	Sitagliptin	Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective
DRUG	Liraglutide	Participant switched to liraglutide if sitagliptin was found not to be effective.
DRUG	Insulin	Participant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required. Insulin was administered to the BL-insulin group at the discretion of the Principal Investigator. Note: OAD and No OAD groups within the non-randomized arm did not take Insulin.
DRUG	Pasireotide LAR	Administered to Acromegaly participants.
DRUG	Metformin	If previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose 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. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator. Note: No OAD group within the non-randomized arm did not take metformin.

Timeline

• Start date: 2014-05-23
• Primary completion: 2018-02-05
• Completion: 2018-03-26
• First posted: 2014-02-12
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

43 sites across 12 countries: United States, Belgium, Brazil, China, Denmark, Germany, India, Peru, Poland, Russia, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study