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Could a Once-Daily steroid pill improve blood sugar control in Dual-Disease patients?

NCT ID NCT05716607

Disease control Sponsor: Vastra Gotaland Region Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether taking hydrocortisone once a day (as a dual-release pill) leads to more stable blood sugar levels compared to the standard three-times-a-day regimen in adults who have both insulin-treated diabetes and Addison's disease. Participants will try both schedules in a random order, and researchers will track glucose patterns, HbA1c, and cortisol levels. The goal is to find a dosing strategy that simplifies treatment while improving glycemic control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Once-daily dual-release hydrocortisone vs thrice-daily immediate-release hydrocortisone
What this could lead to
If it works, this could point toward a simpler, more effective hydrocortisone dosing schedule for people with both diabetes and Addison's disease, potentially improving blood sugar control.
What could go wrong
This is a small, early-stage crossover trial, so results may not apply to everyone. The benefit of once-daily dosing may be modest or absent, and individual responses can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Jan 2025

Finished

Jul 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency autoimmune polyendocrinopathy diabetes mellitus Polyendocrinopathies, Autoimmune primary adrenal insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenal insufficiency Diabetes mellitus Polyglandular autoimmune syndrome

Contacts and locations

Locations

  • Sahlgrenska University Hospital

    Gothenburg, Sweden

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