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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02060383
• Date of registration: 10/02/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
• Scientific title: 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
• Date of first enrolment: May 23, 2014
• Target sample size: 249
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02060383
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, Brazil, China, Denmark, Germany, India, Peru, Poland, Russian Federation, Thailand, Turkey, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients greater than or equal to 18 years old

- Confirmed diagnosis of Cushing's disease or acromegaly

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cushing's Disease

Acromegaly

Intervention(s)

Drug: Pasireotide LAR

Drug: Pasireotide s.c.

Drug: Insulin

Drug: Liraglutide

Drug: Metformin

Drug: Sitagliptin

Primary Outcome(s)

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

Secondary Outcome(s)

Absolute Change in FPG From Baseline to End of Core Phase [Time Frame: Baseline, Up to 32 weeks (end of Core Phase)]

Absolute Change in HbA1c From Baseline to End of Core Phase [Time Frame: Baseline, up to 32 weeks (end of Core phase)]

Change in HbA1c From Randomization (R) Over Time Per Randomized Arm [Time Frame: Randomization (R), Week (W) 4 post R, W 8 post R, W 16 post R, end of Core phase (up to week 16 post R)]

Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin [Time Frame: Randomization to up to 16 weeks]

Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase [Time Frame: Randomization, R(randomization) Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16, end of Core phase]

Percentage of Participants With = 0.3% HbA1c Increase to End of Core Phase [Time Frame: Randomization, up to 16 weeks]

Secondary ID(s)

CSOM230B2219

2012-002916-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02060383