The Diabetes Virus Detection and Intervention Trial

NCT04838145 | Completed Phase 2 DMC

• 1 other identifier: 2015-003350-41
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled study in 96 children and adolescents age 6-15 newly diagnosed with type 1 diabetes to describe the influence of antiviral treatment (Pleconaril and Ribavirin) on progression of disease and residual insulin secretion.

Conditions

Type1 Diabetes Mellitus; Enterovirus

Keywords

Type 1 diabetes; Children; Enterovirus; Recent onset

Outcome Measures

Primary Outcomes (1)

• Insulin secretion

  Change in mean residual insulin secretion in the Insulin tolerance test (ITT)-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to12 months after initiation of study treatment.

  12 months

Secondary Outcomes (12)

• Insulin secretion

  3 months

• Insulin secretion

  6 months

• Insulin secretion

  24 months

• Insulin secretion

  36 months

• Stimulated c-peptide

  36 months

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Pleconaril: 5 mg/kg x2 times a day for 26 weeks up to 40 kg. Max dose 300mg x2. Ribavirin:15 (7.5) mg/kg/day divided in two doses daily for 26 weeks: Max dose 1000mg/24h if body weight\<75kg and 1200mg if body weight\>75kg.

Drug: Ribavirin + Pleconaril

Placebo

PLACEBO COMPARATOR

Receives placebo, on a double blind basis

Drug: Placebos

Interventions

Ribavirin + Pleconaril DRUG

Randomized to treatment with study drugs (ribavirin and pleconaril)

Active treatment

Placebos DRUG

Randomized to treatment with placebo

Placebo

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Must be willing and capable of taking the study drugs and meet for tests and follow up as described.
• Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Conference on Harmonization Good Clinical Practice (ICH GCP), and national/local regulations.

You may not qualify if:

• Treatment with any oral or injected anti-diabetic medications other than insulin.
• A history of haemolytic anaemia or significantly abnormal haematology results at screening.
• History of severe cardiac disease previous six months.
• Impaired renal function
• Patients taking ethinyl estradiol
• Participation in other clinical trials with a new chemical entity within the previous 3 months.
• Inability or unwillingness to comply with the provisions of this protocol
• Females who are lactating or pregnant.
• Males or females (after menarche) not willing to use highly effective contraception (progesterone-only hormonal anticonception with inhibition of ovulation or sexual abstinence) and barrier contraception (condoms), if sexually active during the treatment period and in the following 7 months
• Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Pediatric department, Oslo University Hospital

Oslo, 0514, Norway

Location

MeSH Terms

Conditions

Enterovirus Infections; Diabetes Mellitus, Type 1

Interventions

Ribavirin; pleconaril

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Knut Dahl-Jørgensen, MD, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: A double-blind, placebo controlled, prospective, randomized trial examining the effect of antiviral treatment given for 6months on residual insulin secretion

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: April 8, 2021
• Study Start: August 30, 2018
• Primary Completion: October 25, 2020
• Study Completion: October 25, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)