Last updated on November 2018

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

Brief description of study

The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and safely managed in majority of patients, including those with diabetes at start of pasireotide treatment.

Detailed Study Description

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.

Clinical Study Identifier: NCT02060383

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Novartis Pharmaceuticals

Novartis Investigative Site
San Isidro, Peru

Recruitment Status: Closed

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