Treatment Study in Patients Treated With Both Insulin & Hydrocortisone (INSCORT)

Vastra Gotaland Region

Status: Not yet enrolling

Conditions: Adrenal Insufficiency; Diabetes Mellitus; Polyglandular Autoimmune Syndrome

Treatments: Drug: TID Hydrocortisone; Drug: OD dual-release Hydrocortisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05716607

INS.CORT

Details and patient eligibility

About

The aim of INS.CORT trial is, by studying glycemic variability in a well-defined patient group with both insulin & hydrocortisone (patients with concomitant insulin-treated diabetes & Addison's disease) and collecting information about the administration -time point and doses- of insulin, hydrocortisone and food intake with the help of new technology to improve the treatment in all patients treated with both insulin & glucocorticoids.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Men and women at age 18 to 70 years, with BMI 18-32 kg/m2 and well-defined both insulin-treated diabetes & Addison's disease for >12 months each, on insulin treatment and stable hydrocortisone replacement with once-daily dual-release hydrocortisone (20-30 mg/day) for >3 months.

Exclusion criteria

• Any medication with other glucose lowering agents than insulin
• Any additional underlying or intercurrent disease that may need regular or periodic pharmacological treatment with glucocorticoids during the study period, including infectious diseases
• Any medication with agents which in the investigator's judgement might interfere with the study drugs kinetics, including therapies affecting gastrointestinal emptying or motility
• Any medication with oral estrogen supplementation and/or regular DHEA medication for the past 4 weeks
• Clinically significant renal dysfunction with a serum creatinine above 160 mmol/L
• Active malignancy
• Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepatobiliary/pancreatic disease which in the investigator's judgement may interfere with the study assessment
• Pregnant or lactating women
• Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Once-daily dual-release hydrocortisone

Experimental group

Treatment:

Drug: OD dual-release Hydrocortisone

Thrice-daily conventional immediate-release hydrocortisone

Active Comparator group

Treatment:

Drug: TID Hydrocortisone