Treatment Study in Patients Treated With Both Insulin & Hydrocortisone

NCT05716607 | Not Yet Recruiting

• 1 other identifier: INS.CORT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Adrenal Insufficiency; Polyglandular Autoimmune Syndrome

Keywords

Insulin treatment; Hydrocortisone treatment; Opposing effects on glucose metabolism; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• glycemic variability

  glycemic variability

  4 weeks

Secondary Outcomes (22)

• HbA1c

  4 weeks

• Time in range (glucose)

  4 weeks

• Time above range (glucose)

  4 weeks

• Time below range (glucose)

  4 weeks

• Cortisol exposure-time profile

  4 weeks

Study Arms (2)

Once-daily dual-release hydrocortisone

EXPERIMENTAL

Drug: OD dual-release Hydrocortisone

Thrice-daily conventional immediate-release hydrocortisone

ACTIVE COMPARATOR

Drug: TID Hydrocortisone

Interventions

OD dual-release Hydrocortisone DRUG

Treatment with once-daily dual-release hydrocortisone

Also known as: Once-daily dual-release hydrocortisone

Once-daily dual-release hydrocortisone

TID Hydrocortisone DRUG

Treatment with thrice-daily conventional immediate-release hydrocortisone

Also known as: Thrice-daily conventional immediate-release hydrocortisone

Thrice-daily conventional immediate-release hydrocortisone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• The Swedish Society of Medicine: collaborator
• Åke Wibergs Stiftelse: collaborator
• Sahlgrenska University Hospital: collaborator
• Pilloxa: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Adrenal Insufficiency; Polyendocrinopathies, Autoimmune

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adrenal Gland Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dimitrios Chantzichristos, MD PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Chantzichristos, MD PhD

CONTACT

+46313428547; dimitrios.chantzichristos@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center, randomized, open-label, two-period cross-over trial

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: September 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)