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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: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT02060383 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 249 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Absolute change in HbA1c from randomization to end of core phase (16 weeks) in incretin based therapy arm and insulin arm, and mean difference of change in HbA1c between the two treatment groups based on an ANOVA model using treatment (Incretin, Insulin) and the two randomization stratification factors (Disease: Cushing's disease vs Acromegaly; Baseline glycemic status: HbA1c \<7% vs HbA1c ≥ 7%) as fixed effects. For Participants who discontinued the study or required rescue treatment before the
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 |
What the finished NCT02060383 record still lists
NCT02060383 is an interventional study that assigns participants to a tested intervention. The registered 249 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Sitagliptin is the first listed.
NCT02060383 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02060383's enrollment target sits among peer trials
249 353rd of 2000 higher than 1,648 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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