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

Completed · Phase 4

Conditions studied: Cushing's Disease, Acromegaly

In brief

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.

Key facts

Study ID

NCT02060383

Run by

Novartis Pharmaceuticals

People needed

249

Starts

2014-05-23

Expected to finish

2018-03-26

Last updated by the study team

2019-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients greater than or equal to 18 years old
• Confirmed diagnosis of Cushing's disease or acromegaly

You may not qualify if…

• 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.

Where it is running

• Diabetes and Endocrine Associates La Mesa Location — Multiple Locations, California, United States
• LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219 — Torrance, California, United States
• Coastal Metabolic Research Centre SC — Ventura, California, United States
• East Coast Institute for Research East Coast Inst. for Res(ECIR) — Jacksonville, Florida, United States
• Washington University SC - SOM230B2411 — St Louis, Missouri, United States
• Great Falls Clinic — Great Falls, Montana, United States
• Robert Wood Johnson Medical School - Rutgers SC — New Brunswick, New Jersey, United States
• The Mount Sinai Hospital SC — New York, New York, United States
• Columbia University Medical Center New York Presbyterian Neuroendocrine Unit — New York, New York, United States
• Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC — New York, New York, United States
• Allegheny Endocrinology Associates SC — Pittsburgh, Pennsylvania, United States
• Vanderbilt Clinical Trials Center SOM230B2219 — Nashville, Tennessee, United States
• Baylor College of Medicine Ben Taub General Hosp. — Houston, Texas, United States
• Virginia Endocrinology Research SC-2 — Chesapeake, Virginia, United States
• Swedish Medical Center Dept.ofSeattle Neuroscience(2) — Seattle, Washington, United States
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Joinville, Santa Catarina, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Beijing, Beijing Municipality, China
• Novartis Investigative Site — Guangzhou, Guangdong, China
• Novartis Investigative Site — Chengdu, Sichuan, China
• Novartis Investigative Site — Aalborg, Denmark

Full record on ClinicalTrials.gov

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