Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002916-16-DE

Enrollment

133

Registered

2014-03-17

Start date

2014-08-19

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing's disease and acromegaly MedDRA version: 19.0 Level: LLT Classification code 10011651 Term: Cushing's disease System Organ Class: 100000004860 MedDRA version: 19.0 Level: LLT Classification code 10000600 Term: Acromegaly and gigantism System Organ Class: 100000004860

Interventions

Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 300micrograms Pharmaceutical Form: Solution for injection INN or Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients greater than or equal to 18 years old Confirmed diagnosis of Cushing's disease or acromegaly Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of treatment with incretin based therapy vs. insulin on the 16-week glycemic control in patients with Cushing’s disease or acromegaly who develop or worsen hyperglycemia on pasireotide, and cannot be controlled by metformin alone or other background anti-diabetic treatments ; Secondary Objective: To evaluate the overall effect of anti-diabetic intervention on glycemic control in patients with Cushing’s disease or acromegaly To evaluate the sustainability of glycemic control in the incretin based therapy arm and the insulin arm in Cushing’s disease patients treated with pasireotide s.c. and acromegaly patients treated with pasireotide LAR To evaluate the safety and tolerability of pasireotide in combination with anti-diabetic treatments ;Primary end point(s): Change in HbA1c from randomization to approximately 16 weeks;Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: To evaluate the effect of treatment with incretin based therapy vs. insulin on the 16-week glycemic control in patients with Cushing’s disease or acromegaly who develop or worsen hyperglycemia on pasireotide, and cannot be controlled by metformin alone or other background anti-diabetic treatments ; Secondary Objective: To evaluate the overall effect of anti-diabetic intervention on glycemic control in patients with Cushing’s disease or acromegaly To evaluate the sustainability of glycemic control in the incretin based therapy arm and the insulin arm in Cushing’s disease patients treated with pasireotide s.c. and acromegaly patients treated with pasireotide LAR To evaluate the safety and tolerability of pasireotide in combination with anti-diabetic treatments ;Primary end point(s): Change in HbA1c from randomization to approximately 16 weeks;Timepoint(s) of evaluation of this end point: 16 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Change in HbA1c and FPG from baseline to Core EOP (End of Phase) in patients who received pasireotide by treatment group Proportion of patients with = 0.3% HbA1c increase from baseline to Core EOP per randomized arm Change in HbA1c and FPG from randomization over time and to Core EOP (only for FPG) per randomized arm Proportion of patients who required anti-diabetic rescue therapy with insulin per randomized arm Toxicity will be assessed using NCI-CTC criteria version 4.03 for adverse events. Incidence of hypoglycemia events (# of episodes, # of patients) Clinical chemistry, hematology, urinalysis assessments ECGs Special safety assessments: Thyroid function tests, pancreatic safety tests (for anti-diabetic treatments) and gallbladder examinations ;Timepoint(s) of evaluation of this end point: refer to section 10.5 of the protocol	—

Measure

Time frame

Secondary end point(s): Change in HbA1c and FPG from baseline to Core EOP (End of Phase) in patients who received pasireotide by treatment group Proportion of patients with = 0.3% HbA1c increase from baseline to Core EOP per randomized arm Change in HbA1c and FPG from randomization over time and to Core EOP (only for FPG) per randomized arm Proportion of patients who required anti-diabetic rescue therapy with insulin per randomized arm Toxicity will be assessed using NCI-CTC criteria version 4.03 for adverse events. Incidence of hypoglycemia events (# of episodes, # of patients) Clinical chemistry, hematology, urinalysis assessments ECGs Special safety assessments: Thyroid function tests, pancreatic safety tests (for anti-diabetic treatments) and gallbladder examinations ;Timepoint(s) of evaluation of this end point: refer to section 10.5 of the protocol

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Countries

Belgium, China, Denmark, Germany, Poland, Russian Federation, Turkey, United States

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026