drugset / Trial / NCT03682640

Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes

NCT03682640

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

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 250 mg Oral
Subject Azithromycin Small molecule 500 mg Oral
Subject Insulin Lispro Protein / enzyme biologic Intravenous