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Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02060383
First received: February 10, 2014
Last updated: September 17, 2017
Last verified: September 2017
  Purpose
The study aims to demonstrate that pasireotide-induced hyperglycemia can be effectively and safely managed in majority of patients, including those with diabetes at start of pasireotide treatment.

Condition Intervention Phase
Cushing's Disease Acromegaly Drug: Pasireotide s.c. Drug: Sitagliptin Drug: Liraglutide Drug: Insulin Drug: Pasireotide LAR Drug: Metformin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change in HbA1c from randomization to approximately 16 weeks [ Time Frame: Randomization, 16 weeks ]
    HbA1c change from randomization to approximately 16 weeks in the incretin based therapy arm and insulin arm.


Secondary Outcome Measures:
  • Change in HbA1c and FPG (Fasting Plasma Glucose) from randomization over time and to Core EOP (End of Phase) (only for FPG) per randomized arm [ 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 ]
    The change in HbA1c and FPG from randomization overtime and to the core EOP (only for FPG) will be summarized for each randomized arm.

  • Proportion of patients who required anti-diabetic rescue therapy with insulin in the incretin based arm [ Time Frame: Randomization to up to 16 weeks ]
    The proportion of patients who received anti-diabetic rescue therapy in incretin based therapy will be summarized.

  • Change in HbA1c and FPG from baseline to Core EOP [ Time Frame: Baseline, Up to 32 weeks ]
    Change in HbA1c and FPG from baseline to Core EOP in patients who received pasireotide by treatment group

  • Proportion of patients with ≤ 0.3% HbA1c increase from baseline to Core EOP per randomized arm. [ Time Frame: Baseline, Up to 32 weeks ]
    The proportion of patients with an increase from baseline in HbA1c ≤ 0.3% at Core EOP will be summarized for each randomized arm.

  • Safety and tolerability of pasireotide in combination with anti-diabetic treatments [ Time Frame: Up to 32 weeks ]
    Number of adverse drug events, overall and by severity and number of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, vital signs, thyroid function tests and gallbladder examinations

  • Incidence of hypoglycemia events [ Time Frame: Up to 32 weeks ]
    Summary of the number of treatment emergent hypoglycemia events, as well as the number of patients with hypoglycemia events.


Estimated Enrollment: 246
Actual Study Start Date: May 23, 2014
Estimated Study Completion Date: June 29, 2018
Estimated Primary Completion Date: June 29, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Incretin based therapy
Patients randomized to the incretin based arm will start with sitagliptin once daily. If sitagliptin does not control the patient's hyperglycemia, sitagliptin will be stopped and patients will be switched to liraglutide once daily.
Drug: Pasireotide s.c.
To be administered to Cushing's patients
Drug: Sitagliptin
Taken for 16 weeks or until the drug is found to be not effective
Drug: Liraglutide
Patient will switch to liraglutide if sitagliptin is found to be inefficacious.
Drug: Pasireotide LAR
To be administered to acromegaly patients
Drug: Metformin
If previously normo-glycemic patients experience increases in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they will start anti-diabetic treatment using metformin. If they continue to experience increases in their fasting blood glucose within the first 16 weeks, they will be randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.
Insulin
Patients randomized to the insulin arm may start with once daily dose of basal insulin. The dose may be up or down titrated at the discretion of the investigator. If blood glucose levels remain uncontrolled on basal insulin, patient may be switched to basal insulin plus prandial insulin.
Drug: Pasireotide s.c.
To be administered to Cushing's patients
Drug: Insulin
Patient will take insulin for 16 weeks.
Drug: Pasireotide LAR
To be administered to acromegaly patients
Drug: Metformin
If previously normo-glycemic patients experience increases in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they will start anti-diabetic treatment using metformin. If they continue to experience increases in their fasting blood glucose within the first 16 weeks, they will be randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.

Detailed Description:
This is a Phase IV, multi-center, randomized, open-label study. Eligible patients will start pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for acromegaly. Patients currently treated at screening visit with pasireotide s.c. or LAR are eligible as long as they meet protocol criteria during the screening period. If previously normo-glycemic patients experience increases in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they will start anti-diabetic treatment using metformin. If they continue to have elevated blood sugars above target on metformin within the first 16 weeks, they will be randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients greater than or equal to 18 years old
  • Confirmed diagnosis of Cushing's disease or acromegaly

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060383

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

  Show 47 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02060383     History of Changes
Other Study ID Numbers: CSOM230B2219
2012-002916-16 ( EudraCT Number )
Study First Received: February 10, 2014
Last Updated: September 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's disease
acromegaly
pasireotide
hyperglycemia

Additional relevant MeSH terms:
Acromegaly
Hyperglycemia
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Insulin, Globin Zinc
Insulin
Metformin
Sitagliptin Phosphate
Liraglutide
Incretins
Somatostatin

ClinicalTrials.gov processed this record on September 21, 2017