| Trial ID: | L2222 |
| Source ID: | NCT04589325
|
| Associated Drug: |
Ixekizumab
|
| Title: |
Ixekizumab Diabetes Intervention Trial (I-DIT)
|
| Acronym: |
I-DIT
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type1 Diabetes Mellitus
|
| Interventions: |
DRUG: Ixekizumab|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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., 12 months | Secondary: 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., 12 months|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., 12 months|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., 12 months|HbA1c, Difference in HbA1c from baseline to week 52., 12 months | Other: Time in hypoglycaemia (<3.0 mmol/L), Change in time in hypoglycaemia (\<3.0 mmol/L) measured by CGM/FGM from baseline to week 52., 12 months|Proinsulin/c-peptide ratio in serum as a measure of beta cell stress, Change in proinsulin/c-peptide ratio in serum as a measure of beta cell stress from baseline to week 52., 12 months|Time in target (3.9-8 mmol/L), Change in time in target (3.9-8 mmol/L) measured by CGM/FGM from baseline to week 52., 12 months|Time in hyperglycaemia >10 mmol/L and ≥ 14 mmol/L, Change in time in hyperglycaemia \>10 mmol/L and ≥ 14 mmol/L measured by CGM/FGM from baseline to week 52., 12 months|Glycaemic variability (mean amplitude of glycemic excursions (MAGE)), Change in glycaemic variability measured by mean amplitude of glycemic excursions (MAGE) by CGM/FGM from baseline to week 52., 12 months|Glycaemic variability (coefficient of variation (CV)), Change in glycaemic variability measured by coefficient of variation (CV) by CGM/FGM from baseline to week 52., 12 months|Glycaemic variability (standard deviation (SD)), Change in glycaemic variability measured by standard deviation (SD) by CGM/FGM from baseline to week 52., 12 months|Proportion of patients with peak residual insulin secretion, Change in proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide \>0.4 pmol/mL from baseline to week 52, 12 months|Change in World Health Organization-5 (WHO-5) scores from baseline and week 52., Score 0 to 100; higher value indicates better well-being, 12 months|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) scores from baseline and week 52., Score 0 to 36; higher value indicates better satisfaction and change in satisfaction (score -18 to 18; higher value indicates better change in satisfaction)., 12 months|Change in Hypoglycaemia Fear Survey (Swe-HFS) scores from baseline and week 52., Score 0 to 4; higher value indicates greater fear., 12 months|Change in Problem Areas in Diabetes Scale (PAID) scores from baseline and week 52., Score 0 to 100; higher value indicates greater problems., 12 months|Change in International Physical Activity Questionnaire (IPAQ) scores from baseline and week 52., Total Physical Activity Scores are calculated by Metabolic Energy Turnover (MET)-minutes/week score., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Göteborg University
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
127
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-11-09
|
| Completion Date: |
2027-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-08
|
| Locations: |
Södra Älvsborg Hospital, Borås, Sweden|Falu Lasarett, Falun, Sweden|Sahlgrenska University Hospital, Östra Hospital, Gothenburg, Sweden|Sahlgrenska University Hospital, Sahlgrenska, Göteborg, Sweden|Länssjukhuset Ryhov, Jönköping, Sweden|Karlstad lasarett, Karlstad, Sweden|Kristianstad Hospital, Kristianstad, Sweden|Linköping University Hospital, Linköping, Sweden|Lund University Hospital, Lund, Sweden|Vrinnevi Hospital, Norrköping, Sweden|Skaraborgs sjukhus, Skövde, Sweden|Centrum för Diabetes,, Stockholm, Sweden|Södersjukhuset Hospital, Stockholm, Sweden|NU-Hospital Group, Uddevalla, Sweden|Uppsala Academic Hospital, Uppsala, Sweden|Varbergs sjukhus, Varberg, Sweden|Örebro University Hospital, Örebro, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT04589325
|
