Dual-release hydrocortisone compared to immediate-release glucocorticoid replacement therapy in patients with adrenal insufficiency and diabetes mellitus.

Phase 1

• Conditions: adrenal insufficienty; MedDRA version: 20.0Level: PTClassification code 10001367Term: Adrenal insufficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-004772-21-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

The inclusion criteria for the participants in this study are as follows:
• Males and females older than 18 years up to 90 years of age (women of childbearing age they will perform a high sensitivity pregnancy test to exclude a pregnancy before being included in the study);
• diagnosis of primitive or secondary adrenal insufficiency;
• Stable substitution treatment (same dosage and same active principle) with glucorticoids for at least 6 months;
- Substitution treatment with L-thyroxin and / or fludrocortisone stable at least 3 months before
enrollment
• Concomitant diagnosis of DMT1 or DMT2, in multiinjection insulin therapy or with Oral hypoglycemic agents.
• Affected at the Hospitals' Diabetes / Endocrinology Outpatient Clinic University of Verona;

• optimization of metabolic control prior to entry into the study in the presence of clinically stable HbA1c values ¿¿(variations of less than 0.3%) in the two controls prior to recruitment, spaced at least 3 months apart;
• Signature of informed consent

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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Subjects will be excluded from the study with the following characteristics:
- Pregnant women or fertile age in extroprogestine therapy for contractual purposes;
- breastfeeding women;
- subjects with hypersensitivity to the active substance or to any of the excipients
- Gastrointestinal motility disorders;
- Adrenal insufficiency secondary to the suspension of chronic steroid treatment;
• Cortical-adrenal carcinoma
- Coexistence of other pathologies that may require a treatment cycle high doses of steroids.

Study & Design

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