Cushing's DiseasePhase 4NCT02060383
Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
A Phase 4 study testing Pasireotide s.c., Sitagliptin and Liraglutide in people with Cushing's Disease and Acromegaly, run by Novartis Pharmaceuticals at 43 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Disease, Acromegaly
- What is being tested?
- Pasireotide s.c., Sitagliptin and Liraglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 43 sitesin 12 countries
- Study dates
- 23 May 2014to 26 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater than or equal to 18 years old
- Confirmed diagnosis of Cushing's disease or acromegaly
Who cannot join
- 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.
Trial locations and contacts
43 sites in 12 countries.
43 sites in 12 countries
United States15 sites
Virginia Endocrinology Research SC-2
Chesapeake, Virginia, 23321
Great Falls Clinic
Great Falls, Montana, 59405
Baylor College of Medicine Ben Taub General Hosp.
Houston, Texas, 77030
East Coast Institute for Research East Coast Inst. for Res(ECIR)
Jacksonville, Florida, 32223
Diabetes and Endocrine Associates La Mesa Location
Multiple Locations, California
Vanderbilt Clinical Trials Center SOM230B2219
Nashville, Tennessee, 37212-8210
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
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, 98122-4379
Washington University SC - SOM230B2411
St Louis, Missouri, 63110
LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219
Torrance, California, 90502
Coastal Metabolic Research Centre SC
Ventura, California, 93003
Brazil4 sites
Novartis Investigative Site
Joinville, Santa Catarina, 89201260
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-030
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
Denmark4 sites
Novartis Investigative Site
Aalborg, 9000
Novartis Investigative Site
Aarhus, DK-8000
Novartis Investigative Site
Herlev, DK-2730
Novartis Investigative Site
Odense C, DK-5000
China3 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Germany3 sites
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Oldenburg, 26122
Thailand3 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Songkhla, 90110
Turkey (Türkiye)3 sites
Novartis Investigative Site
Altunizade, 34662
Novartis Investigative Site
Ankara, 06500
Novartis Investigative Site
Antalya, 07070
Belgium2 sites
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Wilrijk, 2610
India2 sites
Novartis Investigative Site
Bangalore, Karnataka, 560054
Novartis Investigative Site
Vellore, Tamil Nadu, 632004
Poland2 sites
Novartis Investigative Site
Warsaw, 00-909
Novartis Investigative Site
Wroclaw, 50 367
About this study
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
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.
Read more
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.
- Conditions
- Cushing's Disease, Acromegaly
- Being tested
- Pasireotide s.c., Sitagliptin, Liraglutide, Insulin, Pasireotide LAR
- Keywords
- Cushing's disease, acromegaly, pasireotide, hyperglycemia
- Medical subject headings
- Pituitary ACTH Hypersecretion, Acromegaly, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide s.c.Drug
Also called SOM230
Administered to Cushing's disease participants.
SitagliptinDrug
Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective
LiraglutideDrug
Participant switched to liraglutide if sitagliptin was found not to be effective.
InsulinDrug
Participant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required.
Insulin was administered to the BL-insulin group at the discretion of the Principal Investigator.
Note: OAD and No OAD groups within the non-randomized arm did not take Insulin.
Pasireotide LARDrug
Also called SOM230
Administered to Acromegaly participants.
MetforminDrug
If previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose 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. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator.
Note: No OAD group within the non-randomized arm did not take metformin.
| Study group | Role | What they receive |
|---|---|---|
| Incretin based therapy (randomized group) | Experimental | Participants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin. Receives: Drug: Pasireotide s.c.; Drug: Sitagliptin; Drug: Liraglutide; Drug: Insulin; Drug: Pasireotide LAR; Drug: Metformin |
| Insulin (randomized group) | Experimental | Participants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin. Receives: Drug: Pasireotide s.c.; Drug: Insulin; Drug: Pasireotide LAR; Drug: Metformin |
| Non-Randomized Arm | Other | This arm represents the non-randomized participants: Cushing's Disease (CD) or Acromegaly participants, who received pasireotide s.c. or LAR (long-acting release) respectively, but who were not randomized to the Incretin or Insulin arms.
For the purpose of analysis, this non-randomized arm is further split into 3 groups:
* Baseline insulin group (BL insulin) includes participants who were receiving insulin at study entry
* Oral antidiabetic drugs (OAD) group includes participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment
* No OAD group includes participants who did not receive any anti-diabetic medication during the core phase of the trial Receives: Drug: Pasireotide s.c.; Drug: Insulin; Drug: Pasireotide LAR; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Randomization to Approximately 16 Weeks
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 time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.
Measured: Randomization, 16 weeks
Secondary outcomes (6)
Change in HbA1c From Randomization (R) Over Time Per Randomized Arm
Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm
Measured: 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)
Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase
Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm
Measured: 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 in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin
The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized.
Measured: Randomization to up to 16 weeks
Absolute Change in HbA1c From Baseline to End of Core Phase
Absolute change in HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm
Measured: Baseline, up to 32 weeks (end of Core phase)
Absolute Change in FPG From Baseline to End of Core Phase
Absolute change in FPG from baseline to end of core phase in the incretin based therapy arm and the insulin arm.
Measured: Baseline, Up to 32 weeks (end of Core Phase)
Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase
Percentage of participants with ≤ 0.3% HbA1c increase in the incretin based therapy arm and the insulin arm.
Measured: Randomization, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study start23 May 2014
- Primary completion5 Feb 2018
- Study completion26 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060383
- Sponsor's protocol ID
- CSOM230B2219
- Other IDs
- 2012-002916-16
- Status last verified
- May 2019
- First submitted
- 10 Feb 2014
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Samson SL, Gu F, Feldt-Rasmussen U, Zhang S, Yu Y, Witek P, Kalra P, Pedroncelli AM, Pultar P, Jabbour N, Paul M, Bolanowski M. Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study. Pituitary. 2021 Dec;24(6):887-903. doi: 10.1007/s11102-021-01161-4. Epub 2021 Jul 18.
PubMed 34275099Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1.
PubMed 27405306
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02060383
- Acronym / sponsor ID
- CSOM230B2219
- Conditions
- Cushing's Disease, Acromegaly
- Keywords
- Cushing's disease, acromegaly, pasireotide, hyperglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 May 2014 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Incretin based therapy (randomized group) | Experimental | Drug: Pasireotide s.c., Drug: Sitagliptin, Drug: Liraglutide, Drug: Insulin, Drug: Pasireotide LAR, Drug: MetforminParticipants randomized to the incretin based arm started with sitagliptin once daily. If sitagliptin did not control the participant's hyperglycemia, sitagliptin was stopped and participants switched to liraglutide once daily. If despite treatment with liraglutide, hyperglycemia was not controlled then the participant was eligible for rescue therapy with addition of insulin. |
| Insulin (randomized group) | Experimental | Drug: Pasireotide s.c., Drug: Insulin, Drug: Pasireotide LAR, Drug: MetforminParticipants randomized to the insulin arm started with once daily dose of basal insulin. The dose was up or down titrated at the discretion of the investigator. If blood glucose levels remained uncontrolled on basal insulin, participant switched to basal insulin plus prandial insulin. |
| Non-Randomized Arm | Other | Drug: Pasireotide s.c., Drug: Insulin, Drug: Pasireotide LAR, Drug: MetforminThis arm represents the non-randomized participants: Cushing's Disease (CD) or Acromegaly participants, who received pasireotide s.c. or LAR (long-acting release) respectively, but who were not randomized to the Incretin or Insulin arms. For the purpose of analysis, this non-randomized arm is further split into 3 groups: * Baseline insulin group (BL insulin) includes participants who were receiving insulin at study entry * Oral antidiabetic drugs (OAD) group includes participants who developed hyperglycemia that was controlled by metformin and/or other background anti-diabetic treatment * No OAD group includes participants who did not receive any anti-diabetic medication during the core phase of the trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients greater than or equal to 18 years old
- Confirmed diagnosis of Cushing's disease or acromegaly
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide s.c.Also: SOM230Administered to Cushing's disease participants. | Drug | Incretin based therapy (randomized group), Insulin (randomized group), Non-Randomized Arm |
| SitagliptinTaken for approximately 16 weeks during the core study phase or until the drug was found not to be effective | Drug | Incretin based therapy (randomized group) |
| LiraglutideParticipant switched to liraglutide if sitagliptin was found not to be effective. | Drug | Incretin based therapy (randomized group) |
| InsulinParticipant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required. Insulin was administered to the BL-insulin group at the discretion of the Principal Investigator. Note: OAD and No OAD groups within the non-randomized arm did not take Insulin. | Drug | Incretin based therapy (randomized group), Insulin (randomized group), Non-Randomized Arm |
| Pasireotide LARAlso: SOM230Administered to Acromegaly participants. | Drug | Incretin based therapy (randomized group), Insulin (randomized group), Non-Randomized Arm |
| MetforminIf previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose 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. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator. Note: No OAD group within the non-randomized arm did not take metformin. | Drug | Incretin based therapy (randomized group), Insulin (randomized group), Non-Randomized Arm |
Primary outcome
Change in HbA1c From Randomization to Approximately 16 Weeks
Time frame: Randomization, 16 weeks
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 time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.
6 secondary outcomes
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)
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 in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin
Time frame: Randomization to up to 16 weeks
Absolute Change in HbA1c From Baseline to End of Core Phase
Time frame: Baseline, up to 32 weeks (end of Core phase)
Absolute Change in FPG From Baseline to End of Core Phase
Time frame: Baseline, Up to 32 weeks (end of Core Phase)
Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase
Time frame: Randomization, up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34275099Samson SL, Gu F, Feldt-Rasmussen U, Zhang S, Yu Y, Witek P, Kalra P, Pedroncelli AM, Pultar P, Jabbour N, Paul M, Bolanowski M. Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study. Pituitary. 2021 Dec;24(6):887-903. doi: 10.1007/s11102-021-01161-4. Epub 2021 Jul 18.
- Derived from this study: PubMed 27405306Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
43 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pasireotide s.c., Sitagliptin and Liraglutide in people with Cushing's Disease and Acromegaly, run by Novartis Pharmaceuticals at 43 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Brazil, Denmark, China, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c From Randomization to Approximately 16 Weeks (time frame: Randomization, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.