Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

Launched by VASTRA GOTALAND REGION · Jan 27, 2023

Keywords

ClinConnect Summary

The INS.CORT trial is a research study that aims to better understand how to manage diabetes and adrenal insufficiency in patients who are taking both insulin and hydrocortisone. This study will look at how blood sugar levels change throughout the day in people with these conditions, and it will gather information on when and how much insulin and hydrocortisone they take, as well as their food intake. The goal is to use this information to improve treatment for all patients who need both types of medication.

To be eligible for this trial, participants must be men or women aged 18 to 70 who have been diagnosed with both insulin-treated diabetes and Addison's disease for more than a year. They should also be on a stable dose of hydrocortisone for at least three months. However, some individuals may not qualify, including those taking other diabetes medications, those with certain health issues, or pregnant or nursing women. If chosen to participate, individuals can expect to provide information about their medication and food habits while contributing to important research that could lead to better treatment options for others in similar situations.

Gender

ALL

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.