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Completed

NCT Number: NCT02060383

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 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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Key information

Conditions

Cushing's Disease Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperpituitarism Hypothalamic Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pasireotide s.c.

Drug

Administered to Cushing's disease participants.

Other names: SOM230

Sitagliptin

Drug

Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective

liraglutide

Drug

Participant switched to liraglutide if sitagliptin was found not to be effective.

Insulin

Drug

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

Drug

Administered to Acromegaly participants.

Other names: SOM230

metformin

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm

  2. 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

    Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm

  3. Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin

    Time frame: Randomization to up to 16 weeks

    The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized.

  4. 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 HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm

  5. Absolute Change in FPG 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 in the incretin based therapy arm and the insulin arm.

  6. Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase

    Time frame: Randomization, up to 16 weeks

    Percentage of participants with ≤ 0.3% HbA1c increase in the incretin based therapy arm and the insulin arm.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2014
Registry last updated
May 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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