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The trial is taking place at:
S

Sahlgrenska University Hospital | Gothia Forum - Clinical Trial Center

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

V

Vastra Gotaland Region

Status

Begins enrollment in 1 month

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)

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

Trial contacts and locations

1

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Central trial contact

Dimitrios Chantzichristos, MD PhD

Data sourced from clinicaltrials.gov

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