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

What Was Tested

This registered phase 4 trial tested Insulin (regular human) and Liraglutide.

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.

It had three arms (groups): Incretin based therapy (randomized group) (experimental), Insulin (randomized group) (experimental) and Non-Randomized Arm (other).

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 249 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients greater than or equal to 18 years old. Confirmed diagnosis of Cushing's disease or acromegaly.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: patients who require surgical intervention; patients receiving dpp-4 inhibitors or glp-1 receptor agonists within 4 weeks prior to study entry; known hypersensitivity to somatostatin analogues other protocol-defined inclusion/exclusion criteria may apply.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-05-23 with completion listed for 2018-02-05.

It ran at 43 sites in United States (15), Brazil (4), Denmark (4), China (3), Germany (3) and Thailand (3).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Randomization to Approximately 16 Weeks (time frame: Randomization, 16 weeks).

It also tracked 6 secondary outcomes, for example Change in HbA1c From Randomization (R) Over Time Per Randomized Arm, Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase, Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin, Absolute Change in HbA1c From Baseline to End of Core Phase and Absolute Change in FPG From Baseline to End of Core Phase.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Liraglutide in 249 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Liraglutide compound page, all human trials.