Study of management of pasireotide-induced hyperglycemia in adult patients with Cushing’s disease or acromegaly
Phase 1
- Conditions
- Cushing's disease and acromegalyMedDRA version: 17.1Level: LLTClassification code 10011651Term: Cushing's diseaseSystem Organ Class: 100000004860MedDRA version: 17.1Level: LLTClassification code 10000600Term: Acromegaly and gigantismSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2012-002916-16-BE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method