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NCT02060383 · ClinicalTrials.gov registry record · Phase 4
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 249
- Enrollment target
NCT02060383 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 249 participants.
The verdict
NCT02060383, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 249 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Sitagliptin
- DRUG Liraglutide
- DRUG Insulin
- DRUG Pasireotide s.c.
- DRUG Pasireotide LAR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2014-05-23 |
| Est. Completion | 2018-03-26 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02060383
The ClinicalTrials.gov registry entry for NCT02060383 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Sitagliptin is the first listed.
NCT02060383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02060383 about?
NCT02060383 is a clinical study titled "Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly". 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 star...
What is the current status of trial NCT02060383?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 249 participants. The study started on 2014-05-23. Estimated completion is 2018-03-26.
What interventions are being tested in trial NCT02060383?
The interventions under investigation include: Sitagliptin (DRUG), Liraglutide (DRUG), Insulin (DRUG), Pasireotide s.c. (DRUG), Pasireotide LAR (DRUG).
Who is sponsoring clinical trial NCT02060383?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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