Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes

NCT03682640 | Unknown Phase 2 DMC

• 1 other identifier: AIDIT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Metabolic Disease; Glucose Metabolism Disorders; Endocrine System Diseases; Juvenile Diabetes; Insulin Dependent Diabetes; Type 1 Diabetes Mellitus; Inflammation; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Stimulated C-peptide during an MMTT

  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.

  12 months after inclusion

Secondary Outcomes (21)

• >60% of time in target blood glucose levels

  two weeks in the 12th month after initiation of the study treatment

• Time in target blood glucose levels

  30 days in the 12th month after initiation of the study treatment

• Time in range blood glucose levels

  30 days in the 12th month after initiation of the study treatment

• Insulin dose

  30 days in the 12th month after initiation of the study treatment

• HbA1c levels

  12 months

Study Arms (2)

AIDIT protocol

EXPERIMENTAL

Treatment as usual with the addition of: i) Azithromycin Monohydrate, three times a week (≥ 48 h between doses) during 52 weeks. 500 mg if body weight ≥ 30 kg, 250 mg if body weight \< 30 kg. ii) Extra intensive insulin treatment periods for maximum beta-cell rest with Insulin lispro (Sanofi). This treatment will be given i.v. for one episode of 72 hours in the first week after inclusion and s.c. on seven 6-8 h occasions during the study year. The dose will be individually titrated to reach target blood glucose 4.0±0.5 mmol/L. ii) Dietician support; Extra advice and support from the study dietician within the first week after randomization and after 1.5 and 4 months.

Drug: Azithromycin Monohydrate; Drug: Insulin Lispro; Behavioral: Dietician support

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.

Interventions

Azithromycin Monohydrate DRUG

Azithromycin Monohydrate tablet (Azithromycin Sandoz) or oral suspension (Azithromax).

Also known as: Azithromycin Sandoz, Azithromax

AIDIT protocol

Insulin Lispro DRUG

Solution for intravenous or subcutaneous use

Also known as: Insulin lispro Sanofi

AIDIT protocol

Dietician support BEHAVIORAL

Dietary advice

AIDIT protocol

Eligibility Criteria

• Age: 72 Months - 192 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Females of childbearing potential must agree to avoid pregnancy during the study period (by abstinence from heterosexual intercourse, or by hormonal or barrier contraception) and have a negative urine pregnancy test.

You may not qualify if:

• 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
• Significantly abnormal haematology results at screening.
• Participation in other clinical trials with a new chemical entity within the previous 3 months.
• Obesity at diagnosis (Iso-BMI ≥ 30 kg/m2 according to http://www.rikshandboken-bhv.se).
• Celiac disease present at diagnosis.
• Treatment with medication known to affect glucohomeostasis, i.e. glucocorticoids (inhaled, nasal or skin topic will be accepted), statins, ACE inhibitors.
• Pregnancy or lactation
• Known gastro-intestinal malabsorption disorders
• Abnormalities in ECG or known cardiac disease
• Known hearing defects
• Known hypersensitivity to penicillin
• Inability or unwillingness to comply with the provisions of this protocol
• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Göteborg University: collaborator

Study Sites (1)

The Queen Silvia Children's Hospital / Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Inflammation

Interventions

Azithromycin; Insulin Lispro

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Gun Forsander, MD, PhD

  The Queen Silvia Children's Hospital /Sahlgrenska University Hospital (SU), Sahlgrenska Academy, Dept of Pediatrics, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olle Korsgren, MD, PhD

CONTACT

+46176114187; olle.korsgren@igp.uu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a 2-arm, randomized, open, clinical trial comparing the AIDIT protocol with treatment as usual.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 24, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

SE (1)