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

Brief Title

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

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

Brief 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. 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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Change in HbA1c From Randomization to Approximately 16 Weeks

Secondary Outcome

 Change in HbA1c From Randomization (R) Over Time Per Randomized Arm

Condition

Cushing's Disease

Intervention

Pasireotide s.c.

Study Arms / Comparison Groups

 Incretin based therapy (randomized group)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

249

Start Date

May 23, 2014

Completion Date

March 26, 2018

Primary Completion Date

February 5, 2018

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT02060383

Organization ID

CSOM230B2219

Secondary IDs

2012-002916-16

Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

May 2019