Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly
NCT ID: NCT02060383
Last Updated: 2019-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
249 participants
INTERVENTIONAL
2014-05-23
2018-03-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Incretin based therapy (randomized group)
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.
Pasireotide s.c.
Administered to Cushing's disease participants.
Sitagliptin
Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective
Liraglutide
Participant switched to liraglutide if sitagliptin was found not to be effective.
Insulin
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 LAR
Administered to Acromegaly participants.
Metformin
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.
Insulin (randomized group)
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.
Pasireotide s.c.
Administered to Cushing's disease participants.
Insulin
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 LAR
Administered to Acromegaly participants.
Metformin
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.
Non-Randomized Arm
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
Pasireotide s.c.
Administered to Cushing's disease participants.
Insulin
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 LAR
Administered to Acromegaly participants.
Metformin
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.
Interventions
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Pasireotide s.c.
Administered to Cushing's disease participants.
Sitagliptin
Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective
Liraglutide
Participant switched to liraglutide if sitagliptin was found not to be effective.
Insulin
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 LAR
Administered to Acromegaly participants.
Metformin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of Cushing's disease or acromegaly
Exclusion Criteria
* Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry
* HbA1c \> 10 % at screening
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Diabetes and Endocrine Associates La Mesa Location
Multiple Locations, California, United States
LA Biomedical Research at Harbor UCLA Medical Center SC - SOM230B2219
Torrance, California, United States
Coastal Metabolic Research Centre SC
Ventura, California, United States
East Coast Institute for Research East Coast Inst. for Res(ECIR)
Jacksonville, Florida, United States
Washington University SC - SOM230B2411
St Louis, Missouri, United States
Great Falls Clinic
Great Falls, Montana, United States
Robert Wood Johnson Medical School - Rutgers SC
New Brunswick, New Jersey, United States
The Mount Sinai Hospital SC
New York, New York, United States
Columbia University Medical Center New York Presbyterian Neuroendocrine Unit
New York, New York, United States
Lenox Hill Hospital/Manhattan Eye, Ear and Throat Hospital SC
New York, New York, United States
Allegheny Endocrinology Associates SC
Pittsburgh, Pennsylvania, United States
Vanderbilt Clinical Trials Center SOM230B2219
Nashville, Tennessee, United States
Baylor College of Medicine Ben Taub General Hosp.
Houston, Texas, United States
Virginia Endocrinology Research SC-2
Chesapeake, Virginia, United States
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, United States
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Wilrijk, , Belgium
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Joinville, Santa Catarina, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Aalborg, , Denmark
Novartis Investigative Site
Aarhus, , Denmark
Novartis Investigative Site
Herlev, , Denmark
Novartis Investigative Site
Odense C, , Denmark
Novartis Investigative Site
Erlangen, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
Oldenburg, , Germany
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Vellore, Tamil Nadu, India
Novartis Investigative Site
San Isidro, Lima region, Peru
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Wroclaw, , Poland
Novartis Investigative Site
Saint Petersburg, , Russia
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Songkhla, , Thailand
Novartis Investigative Site
Altunizade, , Turkey (Türkiye)
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Antalya, , Turkey (Türkiye)
Countries
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References
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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.
Silverstein 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-002916-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSOM230B2219
Identifier Type: -
Identifier Source: org_study_id
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