Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

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.

It had two arms (groups): AIDIT protocol (experimental) and Control (no intervention).

Patients will receive treatment as usual (TAU). All patients will receive standard therapeutic treatment consisting of insulin replacement with insulin analogues aiming for normoglycemia from diagnosis. Rapid acting insulin analogue will be administered via insulin pump (continuous subcutaneous infusion) with access to insulin injections in case of malfunction in the pump system.

The registry classes the interventions as behavioral and drug.

More on the Plan

The study is a 2-arm, randomized, open, single center, clinical trial.

Eligible patients with type 1 diabetes will be randomized to the AIDIT protocol or treatment as usual (TAU).

All patients diagnosed with T1D and included in the study will receive standard of care.

Azithromycin Azithromycin will be administered orally.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 72 months up to 192 months.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinically diagnosed Type 1 Diabetes. First injection of insulin maximum ten days prior to inclusion. Must be willing and capable of taking the study drugs, perform tests and follow up as described as judged by the investigator. Signed informed consent and expected cooperation of the patients for the treatment and follow up. Aged 6.00 -15.99 years at inclusion.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: other diabetes diagnosis than type 1 diabetes as judged by the investigator; severe ketoacidosis (dka) with lowest ph \<7.1 within 36 hours from diagnosis; treatment with any oral or injected anti-diabetic medications other than insulin.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.

It started in 2018-09 with completion listed for 2021-12-31.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Stimulated C-peptide during an MMTT (time frame: 12 months after inclusion).

It also tracked 21 secondary outcomes, for example Time in target blood glucose levels, Time in range blood glucose levels, HbA1c levels, Hypoglycaemic events, Time in hypoglycemic range and IDAA1c.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.