Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
Public ClinicalTrials.gov record NCT02060383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02060383
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 249 participants
Conditions and interventions
Conditions
Interventions
- Pasireotide s.c. Drug
- Sitagliptin Drug
- Liraglutide Drug
- Insulin Drug
- Pasireotide LAR Drug
- Metformin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 23, 2014 (Actual)
- Primary completion
- Feb 5, 2018 (Actual)
- Completion
- Mar 26, 2018 (Actual)
- Last update posted
- May 29, 2019
2014 – 2018
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Diabetes and Endocrine Associates La Mesa Location | Multiple Locations | California | — | — |
| LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219 | Torrance | California | 90502 | — |
| Coastal Metabolic Research Centre SC | Ventura | California | 93003 | — |
| East Coast Institute for Research East Coast Inst. for Res(ECIR) | Jacksonville | Florida | 32223 | — |
| Washington University SC - SOM230B2411 | St Louis | Missouri | 63110 | — |
| Great Falls Clinic | Great Falls | Montana | 59405 | — |
| Robert Wood Johnson Medical School - Rutgers SC | New Brunswick | New Jersey | 08901 | — |
| The Mount Sinai Hospital SC | New York | New York | 10029 | — |
| Columbia University Medical Center New York Presbyterian Neuroendocrine Unit | New York | New York | 10032 | — |
| Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC | New York | New York | 10075 | — |
| Allegheny Endocrinology Associates SC | Pittsburgh | Pennsylvania | 15212 | — |
| Vanderbilt Clinical Trials Center SOM230B2219 | Nashville | Tennessee | 37212-8210 | — |
| Baylor College of Medicine Ben Taub General Hosp. | Houston | Texas | 77030 | — |
| Virginia Endocrinology Research SC-2 | Chesapeake | Virginia | 23321 | — |
| Swedish Medical Center Dept.ofSeattle Neuroscience(2) | Seattle | Washington | 98122-4379 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02060383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 29, 2019 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02060383 live on ClinicalTrials.gov.