EUCTR2012-002916-16-DK
Active, not recruiting
Phase 1
A multi-center, randomized, open-label, Phase IV study toinvestigate the management of pasireotide-inducedhyperglycemia with incretin based therapy or insulin inadult patients with Cushing’s disease or acromegaly.
ConditionsCushing's disease and acromegalyMedDRA version: 19.0Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 100000004860MedDRA version: 19.0Level: LLTClassification code 10000600Term: Acromegaly and gigantismSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
DrugsSignifor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cushing's disease and acromegaly
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 133
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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