The Diabetes Virus Detection and Intervention Trial

• Status: Completed
• Trial end date: 2020-10-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Pleconaril; Ribavirin

Criteria

Inclusion Criteria:

1. Diagnosed type 1 Diabetes (E10.9). First injection of insulin maximum three weeks prior to inclusion.

2. Must be willing and capable of taking the study drugs and meet for tests and follow up as described.

3. 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.

4. Aged 6.00-15.99 years at inclusion

Exclusion Criteria:

1. Treatment with any oral or injected anti-diabetic medications other than insulin.

2. A history of haemolytic anaemia or significantly abnormal haematology results at screening.

3. History of severe cardiac disease previous six months.

4. Impaired renal function

5. Patients taking ethinyl estradiol

6. Participation in other clinical trials with a new chemical entity within the previous 3 months.

7. Inability or unwillingness to comply with the provisions of this protocol

8. Females who are lactating or pregnant.

9. 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

10. Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study.