Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2012-002916-16-DE |
Date of registration:
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17/03/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of management of pasireotide-induced hyperglycemia
in adult patients with Cushing’s disease or acromegaly
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Scientific title:
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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.
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Date of first enrolment:
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19/08/2014 |
Target sample size:
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133 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002916-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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China
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Denmark
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Germany
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Poland
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Russian Federation
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Turkey
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United States
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Contacts
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Name:
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Medizinischer Infoservice (MCC)
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Address:
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Roonstrasse 25
90429
Nürnberg
Germany |
Telephone:
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+491802232300 |
Email:
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infoservice.novartis@novartis.com |
Affiliation:
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Novartis Pharma GmbH |
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Name:
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Medizinischer Infoservice (MCC)
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Address:
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Roonstrasse 25
90429
Nürnberg
Germany |
Telephone:
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+491802232300 |
Email:
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infoservice.novartis@novartis.com |
Affiliation:
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Novartis Pharma GmbH |
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Key inclusion & exclusion criteria
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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: 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
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Hormonal diseases [C19]
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Intervention(s)
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Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 300micrograms Pharmaceutical Form: Solution for injection INN or Proposed INN: PASIREOTIDE Current Sponsor code: SOM230 Other descriptive name: PASIREOTIDE DIASPARTATE Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 300-
Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 600 micrograms Pharmaceutical Form: Solution for injection INN or Proposed INN: PASIREOTIDE Current Sponsor code: SOM230 Other descriptive name: PASIREOTIDE DIASPARTATE Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 600-
Trade Name: Signifor Product Name: pasireotide Product Code: SOM230, 900 micrograms Pharmaceutical Form: Solution for injection INN or Proposed INN: PASIREOTIDE Current Sponsor code: SOM230 Other descriptive name: PASIREOTIDE DIASPARTATE Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 900-
Product Name: pasireotide LAR Product Code: SOM230 LAR, 20 mg Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: PASIREOTIDE Current Sponsor code: SOM230 Other descriptive name: PASIREOTIDE PAMOATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-
Product
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Primary Outcome(s)
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Primary end point(s): Change in HbA1c from randomization to approximately 16 weeks
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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
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Timepoint(s) of evaluation of this end point: 16 weeks
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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
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: refer to section 10.5 of the protocol
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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
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Secondary ID(s)
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CSOM230B2219
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date:
Contact:
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