adrenal insufficienty MedDRA version: 20.0 Level: PT Classification code 10001367 Term: Adrenal insufficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: PLENADREN - 20 MG - COMPRESSA A RILASCIO MODIFICATO - USO ORALE -FLACONE (HDPE) - 50 COMPRESSE
Product Name: Plenadren
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: IDR
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of dual-release hydrocortisone with immediate-release glucocorticoid replacement therapy on glucose control (HbA1c) in patients with adrenal insufficiency and concomitant diabetes mellitus.;Secondary Objective: to evaluate the impact of hydrocortisone on release modified compare to short-lived glucocorticoids in terms of insulin sensitivity, glicemic variability, lipid profile, anthopometric parameters and body composition, blood pressure and heart rate, bone metabolism and quality of life. The safety objectives are: 1. Number of hypoglycaemic episodes 2. hospitalization for acute adrenal crisis;Primary end point(s): For the purpose of evaluating the variation in glycemic charge during treatment with Modified hydrocortisone compared to conventional treatment, the variable being considered will be HbA1c, expressed both in (%) and mmol / mol, measured on visit 3 and on visit 6;Timepoint(s) of evaluation of this end point: visit 3 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For an assessment of the variation in insulin sensitivity, the variable considered will be (SI) [micromol / min / m2 BSA] derived from hyperinsulinemic euglycemic clamp; Any changes in blood pressure (systolic and diastolic), heart rate, lipid profile (total cholesterol levels, HDL, triglyceridaemia and FFA), body weight, abdominal/hip circumference and body composition (percentage fat mass and lean mass found at impedance), Variations in Bone Neoformation Markers (osteocalcin) and Bone Resorption (CTX) concentrations. To evaluate the change in the quality of life, the score of the AddiQoL questionnaire 30 will be compared ; For the purposes of evaluating the variation of glycemic variability, the variables to be calculated from the continuous glucose monitoring are: AUCG (area under the glucose curve) 250 mg / dl, LBGI, HBGI , mean (+/- standard deviation) of 24-hour glucose concentrations and MAGE; the number of severe hypoglycaemic episodes (glycaemia <50 mg / dl) will be compared to the glucometer of each subject over the 6 months of each of the two treatments (safety endpoint). Furthermore, the number of hospitalizations for acute adrenal insufficiency will be compared during each of the two treatments (safety endpoint).;Timepoint(s) of evaluation of this end point: visit 2 and 5; visit 0, 3, 6; visit 1ter and 4; visit 1, 1 bis, 1 ter, 2, 3, 3 bis, 3 ter, 4, 5, 6 | — |
Countries
Italy
Contacts
Public ContactUnit¿ Ricerca Clinica
AZIENDA OSPEDALIERA INTEGRATA UNIVERSITARIA DI VERONA
Outcome results
None listed