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Type1 Diabetes MellitusPhase 2I-DITNCT04589325

Ixekizumab Diabetes Intervention Trial (I-DIT)

A Phase 2 study testing Ixekizumab in people with Type1 Diabetes Mellitus, run by Göteborg University at 17 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Although the clinical onset of type 1 diabetes (T1D) is acute, the progression of T1D occurs over many years often in a patchy manner with inflammation in certain lobes of the pancreas, leaving other lobes unaffected and long-lasting beta cells remain functional decades after diagnosis. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Type1 Diabetes Mellitus
What is being tested?
Ixekizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
17 sitesSweden
Study dates
9 Nov 2022to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations before trial activities are begun.
  • Must be willing and capable of taking the study drugs and meet for tests and follow up as described.
  • Diagnosed Type 1 Diabetes (E10.9) within 100 days.
  • First injection of insulin maximum 100 days prior to screening
  • Aged 18-45 years old.
  • Presence of antibodies at clinical practice or at screening to at least one of the following antigens: insulin/IAA, GAD-65, IA-2 and ZnT8.
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  • Remaining stimulated peak C-peptide ≥ 0.20 nmol/L. If age 36-45 years, peak C-peptide should be <2.0 nmol/L.
  • Male subjects agree to use a reliable method of birth control during the study
  • Female subjects:
  • Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counseled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.
  • If the highly effective contraceptive methods are contraindicated or strictly declined by patient, acceptable birth control methods may be considered. These may include combination of both of the following methods:
  • Male or female condom with spermicide
  • Cap, diaphragm, or sponge with spermicide
  • Highly effective methods of contraception (use 1 form):
  • combined oral contraceptive pill and mini-pill
  • NuvaRing®
  • implantable contraceptives
  • injectable contraceptives (such as Depo-Provera®)
  • intrauterine device (such as Mirena® and ParaGard®)
  • contraceptive patch-ONLY women <198 pounds or 90 kg
  • abstinence from sex
  • vasectomy-for men in clinical studies
  • Effective methods of contraception (use 2 forms combined)
  • male condom with spermicide
  • female condom with spermicide
  • diaphragm with spermicide
  • cervical sponge
  • cervical cap with spermicide
  • Females who are not of childbearing potential include those who have undergone or who have:
  • female sterilization
  • hysterectomy
  • menopause
  • Müllerian agenesis (Mayer-Rokitansky-Küster-Hauser syndrome [also referred to as congenital absence of the uterus and vagina])

Who cannot join

  • Contraindications to Ixekizumab.
  • Treatment with any oral or injected glucose-lowering agents other than insulin.
  • A history of haemolytic anaemia or significantly abnormal haematology/coagulation results at screening.
  • Participation in other clinical trials with a new chemical entity within the previous 3 months.
  • Subjects with severe obesity (BMI >35 kg/m2 if age 18-35 years and BMI >30 kg/m2 if age 36-45).
  • Subjects with other autoimmune disease, e.g. Mb Crohn, Ulcerative colitis, Graves disease, psoriasis, psoriasis arthritis and axial spondylarthrosis, except celiac disease and hypothyroidism which do not need to be excluded for.
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  • Active serious or chronic infections (ie: in case patient had a serious infection (eg pneumonia, cellulitis), has been hospitalized, has received intravenous antibiotics for an infection within 12 weeks prior to screening visit, had a serious bone or joint infection within 24 weeks before screening visit, has ever had an infection of an artificial joint
  • Known immunodeficiency or patient is immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient
  • Tuberculosis
  • History of HIV, hepatitis B or C
  • Active or recurrent fungal infection
  • Subjects with myocardial infarction, stroke, unstable angina or heart failure last 6 months
  • Current clinically significant cardiac arrhythmias as verified by ECG
  • Planned surgery during the treatment period of the study (except minor surgery on skin lesions, e.g., nevus)
  • For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after discontinuation.
  • For male subjects: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness of their partner to use effective contraceptive measures for the duration of the study and 4 months after discontinuation.
  • Any history of malignancy the last 5 years except for completely resected squamous or basal cell carcinoma of the skin.
  • Administration of live attenuated vaccine(s) (LAV) within 2 months of enrolment. Or intended use of LAV during the treatment period.
  • The investigator judges that the clinical diagnosis of T1D set is incorrect or uncertain (needs to be confirmed by discussion with experienced diabetologist if excluding due to this criterion)
  • Allergy against ingredients of the investigational products.
  • Known allergy or hypersensitivity to any biologic therapy (active substance or excipients) that would pose an unacceptable risk to the patient if participating in the study
  • Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study.
  • Liver injury criteria: patients with active hepatobiliary diseases or at screening having alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (>2.5 x ULN)
  • Laboratory abnormalities at screening:
  • Neutrophil count < 1,500 cells/ μL (=1,5 *109 cells/ L)
  • Platelet count < 100,000 cells/ μL (= 100 *109 cells/ L)
  • Hemoglobin < 8.5 g/dL (= <85 g/L) (males) and <8g/dL (= <80 g/L) (women)

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Sweden17 sites

  • Södra Älvsborg Hospital

    Borås

  • Falu Lasarett

    Falun

  • Sahlgrenska University Hospital, Sahlgrenska

    Gothenburg

  • Sahlgrenska University Hospital, Östra Hospital

    Gothenburg

  • Länssjukhuset Ryhov

    Jönköping

  • Karlstad lasarett

    Karlstad

  • Kristianstad Hospital

    Kristianstad

  • Linköping University Hospital

    Linköping

  • Lund University Hospital

    Lund

  • Vrinnevi Hospital

    Norrköping

  • Örebro University Hospital

    Örebro

  • Skaraborgs sjukhus

    Skövde

  • Centrum för Diabetes,

    Stockholm

  • Södersjukhuset Hospital

    Stockholm

  • NU-Hospital Group

    Uddevalla

  • Uppsala Academic Hospital

    Uppsala

  • Varbergs sjukhus

    Varberg

Other trials in Sweden

About this study

Official title: The Effect of Anti-IL17 in New-onset Type 1 Diabetes: a Randomized, Double-blind, Placebo-controlled Trial

Although the clinical onset of type 1 diabetes (T1D) is acute, the progression of T1D occurs over many years often in a patchy manner with inflammation in certain lobes of the pancreas, leaving other lobes unaffected and long-lasting beta cells remain functional decades after diagnosis. Psoriasis share several aspects with T1D, e.g. the patchy inflammatory infiltrate consisting of tissue-resident memory (TRM) T cells, leaky blood vessels that facilitate leukocyte migration and the increased risk for systemic conditions. Moreover, interleukin (IL)-17 has shown to be increased in both persons with psoriasis and T1D. Activation of IL-17/IL-22 pathway is viewed to be both a hallmark of psoriasis and human T1D. Ixekizumab, an anti-IL17 biological agent, has shown marked therapeutic value in the treatment of subjects with psoriasis in several randomized trials and is currently an approved clinical therapy. Due to the many similarities in the current view of pathogenesis and manifestation of T1D and psoriasis it is possible that Ixekizumab can also influence the disease process of T1D.

Read the detailed description

In this double-blind, placebo-controlled prospective trial, patients with newly diagnosed T1D will be randomized to receive either Ixekizumab or placebo in addition to their conventional therapy. The primary aim is to examine the effect of Ixekizumab on endogenous insulin production when administered to persons with newly diagnosed T1D. The planned study duration is 52 weeks with an extension phase for 3 years and includes 127 patients at 17 centers in Sweden. During the extension phase the participants will be examined during a visit after 1 and 3 years after the end of the study regarding insulin production (C-peptide and proinsulin secretion during a Mixed Meal Tolerance Test), glycaemic control, T1D auto-antibodies and insulin doses.

Being tested
Ixekizumab, Placebo
Keywords
Type 1 diabetes, New-onset, MMTT, Ixekizumab
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IxekizumabDrug

    Also called Taltz

    Ixekizumab will be available at a concentration of 80 mg solution for injection in pre-filled syringes.

    Ixekizumab will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months.

  • PlaceboDrug

    Placebo will be available at a concentration of 80 mg solution for injection in pre-filled syringes.

    Placebo will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months.

Study groups in NCT04589325
Study groupRoleWhat they receive
IxekizumabExperimentalNot described
Receives: Drug: Ixekizumab
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Residual insulin secretion

    Change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) between baseline and week 52.

    Measured: 12 months

Secondary outcomes (4)

  1. Mean Insulin dosage per kilo bodyweight for 24 hours

    Change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52.

    Measured: 12 months

  2. Time with glucose levels in range (3.9-10 mmol/L)

    Change in time with glucose levels in range (3.9-10 mmol/l) measured by CGM/FGM from baseline to week 52.

    Measured: 12 months

  3. Time in hypoglycaemia (<3.9 mmol/L)

    Change in time in hypoglycaemia (<3.9 mmol/L) measured by CGM/FGM from baseline to week 52.

    Measured: 12 months

  4. HbA1c

    Difference in HbA1c from baseline to week 52.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start9 Nov 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
127 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589325
Sponsor's protocol ID
IDIT001
Acronym
I-DIT
Status last verified
Apr 2026
First submitted
24 Sep 2020
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Seyed Ahmadi S, Korsgren O, Jansson PA, Lind M. Design and methods of the Ixekizumab Diabetes Intervention Trial (I-DIT): protocol for a phase 2, randomised, multicentre, placebo-controlled, double-blind trial of anti-interleukin 17 as a treatment option for adults with new-onset type 1 diabetes. BMJ Open. 2025 Nov 12;15(11):e103486. doi: 10.1136/bmjopen-2025-103486.

    PubMed 41224288

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixekizumab in people with Type1 Diabetes Mellitus, run by Göteborg University at 17 sites 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 33 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Residual insulin secretion (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04589325, which also lists 1 linked publication.

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 27 Apr 2026.

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