Diabetes MellitusINSCORTNCT05716607
Treatment Study in Patients Treated With Both Insulin & Hydrocortisone
A study testing OD dual-release Hydrocortisone and TID Hydrocortisone in people with Diabetes Mellitus and Adrenal Insufficiency, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Adrenal Insufficiency, Polyglandular Autoimmune Syndrome
- What is being tested?
- OD dual-release Hydrocortisone and TID Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 2 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone
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.
- Being tested
- OD dual-release Hydrocortisone, TID Hydrocortisone
- Keywords
- Insulin treatment, Hydrocortisone treatment, Opposing effects on glucose metabolism, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Adrenal Insufficiency, Polyendocrinopathies, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OD dual-release HydrocortisoneDrug
Also called Once-daily dual-release hydrocortisone
Treatment with once-daily dual-release hydrocortisone
TID HydrocortisoneDrug
Also called Thrice-daily conventional immediate-release hydrocortisone
Treatment with thrice-daily conventional immediate-release hydrocortisone
| Study group | Role | What they receive |
|---|---|---|
| Once-daily dual-release hydrocortisone | Experimental | Not described Receives: Drug: OD dual-release Hydrocortisone |
| Thrice-daily conventional immediate-release hydrocortisone | Active comparator | Not described Receives: Drug: TID Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic variability
glycemic variability
Measured: 4 weeks
Secondary outcomes (22)
HbA1c
HbA1c
Measured: 4 weeks
Time in range (glucose)
Time in range (glucose)
Measured: 4 weeks
Time above range (glucose)
Time above range (glucose)
Measured: 4 weeks
Time below range (glucose)
Time below range (glucose)
Measured: 4 weeks
Cortisol exposure-time profile
Cortisol exposure-time profile
Measured: 4 weeks
systolic blood pressure
systolic blood pressure in sitting position
Measured: 4 weeks
diastolic blood pressure
diastolic blood pressure in sitting position
Measured: 4 weeks
ADDIQoL
questionnaire: the Addison-specific quality-of-life (ADDIQoL)
The AddiQoL is a 36-item questionnaire; each item contains six scoring categories. Twenty-five items are negative Health-Related Quality of Life (HRQoL) statements that need to be reversed for questionnaire scoring; thus, a higher score indicates a higher level of HRQoL.
Measured: 4 weeks
PGWB
questionnaire: the Psychological General Well-Being (PGWB) index
The Psychological General Well-Being Index (PGWBI) is a measure of the level of subjective psychological well-being. In detail, it assesses self-representations of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress and thus captures what we could call a subjective perception of well-being. Consisting of 22 standardized items (6 items for the short form), the tool produces a single measure of psychological well-being. The full measure also provides sub-scales to assess the following domains: anxiety, depression, positive well-being, self-control, general health, and vitality.
Measured: 4 weeks
FIS
questionnaire: the Fatigue Impact Scale (FIS)
The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning minimum and maximum values, and whether higher scores mean a better or worse outcome.
Higher scores mean a worse outcome. Min 0 points, max 160 points.
Measured: 4 weeks
FOSQ
questionnaire: the Functional Outcomes of Sleep Questionnaire (FOSQ)
Disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. Name of categories assessed: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty).
Higher scores mean a better outcome. Min 0 points, max 120 points.
Measured: 4 weeks
Fever
Incidence of infections with high fever (patients judgement)
Measured: 4 weeks
CD16
immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble CD16
Measured: 4 weeks
ADAM17
immunophenotyping of peripheral blood mononuclear cells (PBMCs) with measurement of soluble ADAM17
Measured: 4 weeks
transcriptomics
RNA sequencing for large-scale study of gene expression in circulation
Measured: 4 weeks
microRNAs
large-scale study of microRNAs in circulation
Measured: 4 weeks
proteomics
large-scale study of proteomes (proteins produced in study subjects)
Measured: 4 weeks
metabolomics
large-scale study of metabolome (metabolites produced in study subjects)
Measured: 4 weeks
hsCRP fibrinogen, immunoglobulin
High-sensitivity C-reactive Protein (laboratory measurement)
Measured: 4 weeks
SR
erythrocyte sedimentation rate (laboratory measurement)
Measured: 4 weeks
fibrinogen
fibrinogen (laboratory measurement)
Measured: 4 weeks
immunoglobulins
immunoglobulin levels in fem klasser: IgA, IgD, IgE, IgG och IgM
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jan 2025
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Why it stopped: The study was terminated because of insufficient funding to complete the planned research activities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, randomized, open-label, two-period cross-over trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- The Swedish Society of Medicine, Sahlgrenska University Hospital, Pilloxa
- Responsible party
- Principal investigator, DimitriosChantzichristos, Vastra Gotaland Region
- Investigators
- Dimitrios Chantzichristos, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716607
- Sponsor's protocol ID
- INS.CORT
- Acronym
- INSCORT
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Trial in Patients Treated With Both Insulin & Hydrocortisone
- ClinicalTrials.gov ID
- NCT05716607
- Acronym / sponsor ID
- INSCORT / INS.CORT
- Keywords
- Insulin treatment, Hydrocortisone treatment, Opposing effects on glucose metabolism, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated because of insufficient funding to complete the planned research activities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- The Swedish Society of Medicine, Sahlgrenska University Hospital, Pilloxa
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, open-label, two-period cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Once-daily dual-release hydrocortisone | Experimental | Drug: OD dual-release Hydrocortisone |
| Thrice-daily conventional immediate-release hydrocortisone | Active comparator | Drug: TID Hydrocortisone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OD dual-release HydrocortisoneAlso: Once-daily dual-release hydrocortisoneTreatment with once-daily dual-release hydrocortisone | Drug | Once-daily dual-release hydrocortisone |
| TID HydrocortisoneAlso: Thrice-daily conventional immediate-release hydrocortisoneTreatment with thrice-daily conventional immediate-release hydrocortisone | Drug | Thrice-daily conventional immediate-release hydrocortisone |
Primary outcome
glycemic variability
Time frame: 4 weeks
glycemic variability
22 secondary outcomes
HbA1c
Time frame: 4 weeks
Time in range (glucose)
Time frame: 4 weeks
Time above range (glucose)
Time frame: 4 weeks
Time below range (glucose)
Time frame: 4 weeks
Cortisol exposure-time profile
Time frame: 4 weeks
systolic blood pressure
Time frame: 4 weeks
diastolic blood pressure
Time frame: 4 weeks
ADDIQoL
Time frame: 4 weeks
PGWB
Time frame: 4 weeks
FIS
Time frame: 4 weeks
FOSQ
Time frame: 4 weeks
Fever
Time frame: 4 weeks
CD16
Time frame: 4 weeks
ADAM17
Time frame: 4 weeks
transcriptomics
Time frame: 4 weeks
microRNAs
Time frame: 4 weeks
proteomics
Time frame: 4 weeks
metabolomics
Time frame: 4 weeks
hsCRP fibrinogen, immunoglobulin
Time frame: 4 weeks
SR
Time frame: 4 weeks
fibrinogen
Time frame: 4 weeks
immunoglobulins
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Chantzichristos, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OD dual-release Hydrocortisone and TID Hydrocortisone in people with Diabetes Mellitus and Adrenal Insufficiency, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic variability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.