2026-04-24
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 17 of 17 sites
2024-11-07
minor
Study Status, Sponsor/Collaborators, Study Description, Eligibility, Contacts/Locations v6
Eligibility criteria+111 characters
[...] tion of insulin maximum 100 days prior to screening
Aged 18-3545 years old.
Presence of antibodies at clinical practice or a [...] and ZnT8.
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 contro [...] evious 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, Ulce [...]
Study descriptionrevised
[...] an extension phase for 3 years and includes 127 patients at 1917 centers in Sweden.
During the extension phase the participa [...]
Collaborators-67 characters
Gothia Forum - Center for Clinical Trial
Statistiska Konsultgruppen
2023-11-09
minor
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v5
Study sites18→15
Lead sponsorVastra Gotaland Region→Göteborg University
2022-12-05
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-10→confirmed 2022-11-09
Eligibility criteria+49 characters
[...] inically significant cardiac arrhythmias as verified by ECG
SurgeryPlanned surgery during the treatment period of the study (except minor surgery on skin lesions, e.g., nevus)
For fem [...]
Study sitesdetails revised at 18 of 18 sites
2022-10-03
minor
Study Status, Eligibility v3
Start date2022-09→2022-10
Eligibility criteria+60 characters
[...] inically significant cardiac arrhythmias as verified by ECG
Surgery (except minor surgery on skin lesions, e.g., nevus)
For female subjects: Positive pregnancy test, presently brea [...]
Show 2 earlier versions
2022-06-15
minor
Study Status, Sponsor/Collaborators, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
Eligibility criteria+405 characters
InclusionINCLUSION criteriaCRITERIA:
Signed informed consent and expected cooperation of the pa [...] nd follow up as described.
Diagnosed Type 1 Diabetes (E10.9)
within less100 than 8 weeksdays.
First injection of insulin maximum 8100 weeksdays prior to screening.
Aged 18-35 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.
Remaining stimulated peak C-peptide ≥ 0.20 nmol/L.
Male subjects agree to use a reliable method of birth control during the study.
Female subjects:
Participants of childbearing age [...] [...]
Secondary endpoints4 entries, revised
Change in meanMean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52.
Change in timeTime with glucose levels in range (3.9-10 mmol/lL) measured by CGM/FGM from baseline to week 52.
ChangeTime in time of hypoglycaemia (<3.9 mmol/lL) measured by CGM/FGM from baseline to week 52.
Difference in HbA1c from baseline to week 52.
Primary endpoints1 entry, revised
The primary endpoint is change in residualResidual 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.
Collaborators4 to 2 entries
Eli Lilly and Company
Karolinska University Laboratory
2021-08-23
minor
Study Status, Study Description, Study Design, Eligibility v1
Primary completion date2022-02→2027-02
Completion date2025-12→2027-12
Start date2021-02→2022-09
Enrollment target74→127
Eligibility criteria+1,965 characters
[...] e to use a reliable method of birth control during the study.
Female subjects:
Participants of childbearing age or childb [...] 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
Highl [...] Exclusion Crite [...] [...]
Study description+1 characters
[...] s 52 weeks with an extension phase for 3 years and includes 74127 patients at 19 centers in Sweden.
During the extension phas [...]
2020-10-14
minor
Original filing