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

Phase 1

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

• Registration Number: EUCTR2012-002916-16-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-17
• Study Completion: 2018-03-26
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 249

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified