Treatment Study in Patients Treated With Both Insulin & Hydrocortisone (INSCORT)
Diabetes Mellitus, Adrenal Insufficiency, Polyglandular Autoimmune Syndrome
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Insulin treatment, Hydrocortisone treatment, Opposing effects on glucose metabolism, Randomized Controlled Trial
Eligibility Criteria
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.
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Once-daily dual-release hydrocortisone
Thrice-daily conventional immediate-release hydrocortisone