Type 1 diabetes
Conditions
Interventions
Trade Name: Azithromycin Sandoz 250 mg och 500 mg filmdragerade tabletter
Pharmaceutical Form:
Trade Name: Insulin lispro Sanofi 100 enheter/ml injektionsvätska, lösning i cylinderampull
Pharmaceuti
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically diagnosed Type 1 Diabetes. First injection of insulin maximum ten days prior to inclusion. 2. Must be willing and capable of taking the study drugs, perform tests and follow up as described as judged by the investigator. 3. Signed informed consent and expected cooperation of the patients for the treatment and follow up. 4. Aged 6.00 -15.99 years at inclusion. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other diabetes diagnosis than Type 1 diabetes as judged by the investigator 2. Severe ketoacidosis (DKA) with lowest pH <7.1 within 36 hours from diagnosis. 3. Treatment with any oral or injected anti-diabetic medications other than insulin 4. Significantly abnormal haematology results at screening. 5. Participation in other clinical trials with a new chemical entity within the previous 3 months. 6. Obesity at diagnosis (Iso-BMI = 30 kg/m2 according to http://www.rikshandboken-bhv.se). 7. Other autoimmune disease present at inclusion that in the opinion of the investigator would interfere with the study protocol. 8. Celiac disease present at diagnosis. 9. Treatment with medication known to affect glucohomeostasis, i.e. glucocorticoids (inhaled, nasal or skin topic will be accepted), statins, ACE inhibitors. 10. Pregnancy or lactation 11. Known gastro-intestinal malabsorption disorders 12. Abnormalities in ECG or known cardiac disease 13. Known hearing defects 14. Known hypersensitivity to penicillin 15. Inability or unwillingness to comply with the provisions of this protocol 16. Presence of serious disease or condition in patient or family, which in the opinion of the investigator makes the patient non-eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Study Objective: Describe the influence of the Azithromycin Insulin Diet intervention trial (AIDIT) protocol consisting of long-term Azithromycin treatment combined with insulin-induced beta-cell rest and nutritional intervention on beta cell preservation in children newly diagnosed with Type 1 Diabetes. Primary objective: To compare the AIDIT protocol with treatment as usual at 12 months after diagnosis with respect to residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide. ;Secondary Objective: Secondary objectives: To compare the two treatment regimens with respect to a number of defined variables, listed in the study protocol section 2.5. ;Primary end point(s): Residual insulin secretion measured by mixed meal tolerance test (MMTT) stimulated C-peptide two-hour under the curve profile measured one year after study inclusion.;Timepoint(s) of evaluation of this end point: 12 months after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of subjects with time in target 3.9-7.8 mmol/L = 60% and with a glycaemic variability expressed as standard deviation < 2 mmol/L according to continuous glucose monitoring during two weeks in the 12th month after initiation of the study treatment. 2. Time in target (3.9-7.8 mmol/L) during 30 days in the 12th month after initiation of the study treatment. 3. Time in range (3.9-10 mmol/L) during 30 days in the 12th month after initiation of the study treatment. 4. Mean daily insulin dosage per kilo bodyweight during 30 days in the 12th month after initiation of the study treatment.. 5. HbA1c at 12 months after study initiation 6. Number of severe hypoglycaemic events (hypoglycaemia level 3) during the study year. 7. Time in hypoglycaemic range level 1 and 2 (<3.9 mmol/l and <3.0 mmol/l) respectively in CGM registrations during 30 days in the 12th month after initiation of the study treatment. 8. Insulin-dose-adjusted HbA1c (IDAA1c) 12 months after study initiation 9. Pro-insulin/c-peptide ratio in serum 12 months after study initiation 10. Inflammation in the pancreas measured by contrast enhanced MRI at 12 months after initiation of the study 11. Health related Quality of Life; Varni PedsQL, Generic and Diabetes specific questionnaire, by child and proxy (parents or other caregivers) at study start and 12 months after study initiation. 12. Questionnaire on gastrointestinal symptoms: ”The gastrointestinal symptom rating scale” (GSRS) at study start and 12 months after study initiation . 13. Average time spent eating at meals during four days in the 12th month after initiation of the study treatment. 14. Intake of saturated fat (E% and if the child reaches Nordic Nutritional Recommendations, NNR) during four days in the 12th month after initiation of the study treatment. 15. Intake of fruit and vegetables (g/day and if the child reaches NNR) during four days in the 12th month after initiation of the study treatment. 16. Intake of | — |
Countries
Sweden
Contacts
Public ContactOlle Korsgren
Uppsala University
Outcome results
None listed