drugset / Trial / NCT03682640
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
RandomizedParallel-groupOpen-labelTreatment
Summary
Increasing evidences suggest that infections are important etiological factors for the development of Type 1 Diabetes (T1D). The overall hypothesis of the study is that the treatment of children, during the first year after diagnosis of T1D with Azithromycin, combined with repeated episodes of intensified insulin treatment to induce maximal beta-cell rest, and dietician support to promote dietary habits that minimize the likelihood of bacterial reflux from the duodenum to the pancreatic duct, will lead to preservation of beta cell function. This trial will examine whether the AIDIT protocol initiated within one week from diagnosis could preserve insulin production in children with Type 1 Diabetes.
Timeline
- Start
- 2018-09
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 250 mg | Oral |
| Subject | Azithromycin | Small molecule | 500 mg | Oral |
| Subject | Insulin Lispro | Protein / enzyme biologic | — | Intravenous |