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Withdrawn
NCT05716607
Treatment Study in Patients Treated With Both Insulin & Hydrocortisone
Conditions: Diabetes Mellitus, Adrenal Insufficiency, Polyglandular Autoimmune Syndrome
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Sponsor: Vastra Gotaland Region
Location: Sahlgrenska University Hospital Gothenburg
Summary
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.
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.
Source: ClinicalTrials.gov (NCT05716607). StuddyBuddy aggregates publicly available trial information.