← Trials/Trial dossier/NCT02060383
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
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
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
43
Recruiting sites
—
Enrollment
249
actual
Study population
Diabetes (other / unspecified)
Key I/E criterion
—
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Glycemic / diabetes
14 endpointsChange in HbA1c From Randomization to Approximately 16 Weeks
Time frame:Randomization, 16 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Hba1c percentage | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group)All Patients | -0.12 | -0.36 – 0.13 |
| Cushing's Disease | 0.33 | -0.41 – 1.07 |
| Acromegaly | -0.25 | -0.49 – -0.00 |
| Insulin (Randomized Group)All Patients | 0.26 | -0.01 – 0.53 |
| Cushing's Disease | 0.45 | -0.20 – 1.09 |
| Acromegaly | 0.19 | -0.12 – 0.49 |
All Patients
Cushing's Disease
Acromegaly
Change in HbA1c From Randomization to Approximately 16 Weeks
Time frame:Randomization, 16 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), HbA1c percentage | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group)Randomization | 7.1 | — |
| Change at RW4 D29 | 0.5 | — |
| Change at RW8 D57 | 0.3 | — |
| Change at RW12 D85 | 0.2 | — |
| Change at RW16 D113 | 0.0 | — |
| End of Core Phase | 0.0 | — |
| Insulin (Randomized Group)Randomization | 7.1 | — |
| Change at RW4 D29 | 0.5 | — |
| Change at RW8 D57 | 0.5 | — |
| Change at RW12 D85 | 0.4 | — |
| Change at RW16 D113 | 0.3 | — |
| End of Core Phase | 0.3 | — |
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
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group)Randomization | 172.2 | — |
| Change at RW2 D15 | 4.6 | — |
| Change at RW4 D29 | -15.0 | — |
| Change at RW6 D43 | -17.7 | — |
| Change at RW8 D57 | -25.7 | — |
| Change at RW10 D71 | -28.8 | — |
| Change at RW12 D85 | -33.4 | — |
| Change at RW14 D99 | -35.1 | — |
| Change at RW16 D113 | -38.8 | — |
| End of Core Phase | -40.1 | — |
| Insulin (Randomized Group)Randomization | 167.9 | — |
| Change at RW2 D15 | -31.1 | — |
| Change at RW4 D29 | -28.3 | — |
| Change at RW6 D43 | -37.5 | — |
| Change at RW8 D57 | -38.3 | — |
| Change at RW10 D71 | -36.9 | — |
| Change at RW12 D85 | -41.1 | — |
| Change at RW14 D99 | -35.6 | — |
| Change at RW16 D113 | -33.4 | — |
| End of Core Phase | -36.0 | — |
Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin
Time frame:Randomization to up to 16 weeks
threshold achievement, event
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group) | 31.6 | 17.5 – 48.7 |
Absolute Change in HbA1c From Baseline to End of Core Phase
Time frame:Baseline, up to 32 weeks (end of Core phase)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), HbA1c percentage | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group)Baseline: All Patients | 6.3 | — |
| Change at EOP: All Patients | 0.8 | — |
| Baseline: Cushing's | 6.6 | — |
| Change at EOP: Cushing's | 1.3 | — |
| Baseline: Acromegaly | 6.1 | — |
| Change at EOP: Acromegaly | 0.6 | — |
| Insulin (Randomized Group)Baseline: All Patients | 6.3 | — |
| Change at EOP: All Patients | 1.1 | — |
| Baseline: Cushing's | 6.5 | — |
| Change at EOP: Cushing's | 1.7 | — |
| Baseline: Acromegaly | 6.3 | — |
| Change at EOP: Acromegaly | 0.8 | — |
| Baseline Insulin (BL) (Non-randomized Group)Baseline: All Patients | 7.7 | — |
| Change at EOP: All Patients | 1.3 | — |
| Baseline: Cushing's | 6.9 | — |
| Change at EOP: Cushing's | 1.4 | — |
| Baseline: Acromegaly | 8.0 | — |
| Change at EOP: Acromegaly | 1.2 | — |
| Oral Antidiabetic Drugs (OAD) (Non-randomized Group)Baseline: All Patients | 5.7 | — |
| Change at EOP: All Patients | 0.8 | — |
| Baseline: Cushing's | 5.9 | — |
| Change at EOP: Cushing's | 0.9 | — |
| Baseline: Acromegaly | 5.6 | — |
| Change at EOP: Acromegaly | 0.7 | — |
| No OAD (Non-randomized Group)Baseline: All Patients | 5.4 | — |
| Change at EOP: All Patients | 0.4 | — |
| Baseline: Cushing's | 5.5 | — |
| Change at EOP: Cushing's | 0.5 | — |
| Baseline: Acromegaly | 5.4 | — |
| Change at EOP: Acromegaly | 0.4 | — |
Absolute Change in FPG From Baseline to End of Core Phase
Time frame:Baseline, Up to 32 weeks (end of Core Phase)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group)Baseline: All Patients | 111.1 | — |
| Change at EOP: All Patients | 22.2 | — |
| Baseline: Cushing's | 117.9 | — |
| Change at EOP: Cushing's | 13.4 | — |
| Baseline: Acromegaly | 107.9 | — |
| Change at EOP: Acromegaly | 26.5 | — |
| Insulin (Randomized Group)Baseline: All Patients | 111.8 | — |
| Change at EOP: All Patients | 22.5 | — |
| Baseline: Cushing's | 106.3 | — |
| Change at EOP: Cushing's | 36.4 | — |
| Baseline: Acromegaly | 114.2 | — |
| Change at EOP: Acromegaly | 16.7 | — |
| Baseline Insulin (BL) (Non-randomized Group)Baseline: All Patients | 157.7 | — |
| Change at EOP: All Patients | 9.8 | — |
| Baseline: Cushing's | 147.2 | — |
| Change at EOP: Cushing's | 21.3 | — |
| Baseline: Acromegaly | 162.5 | — |
| Change at EOP: Acromegaly | 4.6 | — |
| Oral Antidiabetic Drugs (OAD) (Non-randomized Group)Baseline: All Patients | 97.2 | — |
| Change at EOP: All Patients | 22.9 | — |
| Baseline: Cushing's | 93.3 | — |
| Change at EOP: Cushing's | 15.8 | — |
| Baseline: Acromegaly | 98.8 | — |
| Change at EOP: Acromegaly | 25.8 | — |
| No OAD (Non-randomized Group)Baseline: All Patients | 92.2 | — |
| Change at EOP: All Patients | 16.3 | — |
| Baseline: Cushing's | 85.5 | — |
| Change at EOP: Cushing's | 11.7 | — |
| Baseline: Acromegaly | 93.4 | — |
| Change at EOP: Acromegaly | 17.0 | — |
Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase
Time frame:Randomization, up to 16 weeks
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (number), Percentage of participants | 95% CI |
|---|---|---|
| Incretin Based Therapy (Randomized Group) | 73.7 | 56.9 – 86.6 |
| Insulin (Randomized Group) | 65.1 | 49.1 – 79.0 |
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)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
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
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin
Time frame:Randomization to up to 16 weeks
threshold achievement, improvement
Absolute Change in HbA1c From Baseline to End of Core Phase
Time frame:Baseline, up to 32 weeks (end of Core phase)
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Absolute Change in FPG From Baseline to End of Core Phase
Time frame:Baseline, Up to 32 weeks (end of Core Phase)
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase
Time frame:Randomization, up to 16 weeks
threshold achievement, improvement
LOINC 4548-4
Publications (3)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Frontiers in endocrinology2024 (year)PMID38577574doi:10.3389/fendo.2024.1250822via pubmed nct search
- Pituitary2021 Dec (month)PMID34275099doi:10.1007/s11102-021-01161-4via clinicaltrials gov reference derived + pubmed nct search
- Pituitary2016 Oct (month)PMID27405306doi:10.1007/s11102-016-0734-1via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.