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

• Register: EUCTR
• Last refreshed on: 7 May 2018
• Main ID: EUCTR2012-002916-16-PL
• Date of registration: 16/03/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly
• Scientific 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.
• Date of first enrolment: 29/06/2015
• Target sample size: 133
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002916-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
Patients greater than or equal to 18 years old

Confirmed diagnosis of Cushing's disease or acromegaly

Additional inclusion criteria as per full protocol may apply.
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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Intervention(s)

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
CAS Number: 396091-77-3
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
CAS Number: 396091-77-3
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.6-

Trade Name: Signifor
Product Name: pasireotide
Product Code: SOM230
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
CAS Number: 396091-77-3
Current Sponsor code: SOM230
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.9-

Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: pasireotide pamoate
CAS Number: 396091-79-5
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE PAMOATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: PASIREOTIDE PAMOATE
CAS Number: 396091-79-5
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE PAMOATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Signifor
Product Name: pasireotide LAR
Product Code: SOM230 LAR
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: PASIREOTIDE PAMOATE
CAS Number: 396091-79-5
Current Sponsor code: SOM230
Other descriptive name: PASIREOTIDE PAMOATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Objective: 1. To evaluate the overall effect of anti-diabetic intervention on glycemic control in patients with Cushing’s disease or acromegaly
2. 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
3. To evaluate the safety and tolerability of pasireotide in combination with anti-diabetic treatments

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

Primary end point(s): Change in HbA1c from randomization to approximately 16 weeks

Secondary Outcome(s)

Secondary end point(s): 1.
- Change in HbA1c and FPG from baseline to Core EOP (End of Phase) in patients who received pasireotide by treatment group
2.
- 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
3.
- 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

Secondary ID(s)

2012-002916-16-DE

CSOM230B2219

Source(s) of Monetary Support

Novartis Pharma Services AG