Study S002111

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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02060383
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 249
Start: 2014-05-23
Primary completion: 2018-02-05
Lead sponsor: Novartis Pharmaceuticals
Conditions: Cushing's Disease; Acromegaly
Interventions: DRUG:Pasireotide s.c.; DRUG:Sitagliptin; DRUG:Liraglutide; DRUG:Insulin; DRUG:Pasireotide LAR; DRUG:Metformin
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2012-002916-16

Registered primary outcomes

Change in HbA1c From Randomization to Approximately 16 Weeks [Randomization, 16 weeks]

Linked records (5)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0019440	Predictive factors and the management of hyperglycemia in patients with acromegaly and Cushing's disease receiving pasireotide treatment: post hoc analyses from the SOM230B2219 study. Feldt-Rasmussen U, Frontiers in endocrinology	2024	Randomized trial	PMID 38577574 DOI	cites ClinicalTrials.gov:NCT02060383
R0048580	Managing high blood sugar (hyperglycemia) during pasireotide treatment: A plain language summary of the B2219 study Susan Leanne Samson, Future Rare Diseases	2024	Other trial	DOI	cites ClinicalTrials.gov:NCT02060383
R0050551	THU054 A Post Hoc Analysis Of The Phase IV B2219 Study To Determine Predictive Factors For Hyperglycemia During Treatment With Pasireotide Susan Leanne Samson, Journal of the Endocrine Society	2023	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02060383
R0012861	Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study. Samson SL, Pituitary	2021	Randomized trial	PMID 34275099 DOI	cites ClinicalTrials.gov:NCT02060383; registry reference DERIVED:34275099
R0016918	MON-LB079 A Multicenter, Randomized, Open-Label, Phase IV Study Investigating Management of Pasireotide-Associated Hyperglycemia with Incretin-Based Therapy or Insulin in Patients with Acromegaly or Cushing's Disease (CD) Samson S, Journal of the Endocrine Society	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02060383