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Type1 Diabetes MellitusPhase 2DiViDIntNCT04838145

The Diabetes Virus Detection and Intervention Trial

A Phase 2 study testing Ribavirin + Pleconaril in people with Type1 Diabetes Mellitus and Enterovirus, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 15 years
Conditions the study is for
Type1 Diabetes Mellitus, Enterovirus
What is being tested?
Ribavirin + Pleconaril
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteNorway
Study dates
30 Aug 2018to 25 Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosed type 1 Diabetes (E10.9). First injection of insulin maximum three weeks prior to inclusion.
  • 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.
  • Aged 6.00-15.99 years at inclusion

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Pediatric department, Oslo University Hospital

    Oslo, 0514

Other trials in Norway

About this study

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.

Read the detailed description

If antiviral treatment is efficient in halting the disease progression, it will be to great benefit for the participating patients. Maintenance or even an increase in beta cell mass due to regeneration will lead to improved endogenous insulin production and give a milder course of the disease with improved glycemic control. This will in a substantial way improve the long-term prognosis with less severe long term vascular complications.Some patients may have close to complete remission and be able to stop insulin treatment. If antiviral treatment is effective, it would add proof to the concept that type 1 diabetes in its origin is a viral disease. This would be an important milestone in medical research and a breakthrough in the understanding of the etiopathogenesis of autoimmune diseases. It may promote the development of vaccines to prevent the disease. T1D seems more aggressive in children than in adults, and the beta cell function decline rapidly compared to adults. As a consequence, the effect of antiviral treatment will potentially be more significant in children than in adults. Children have higher HbA1c which increases the risk of complications. Thus, T1D is a more aggressive disease in children than in adults and hence it's important to do this study in children. Pharmaceuticals are usually studied in different age intervals, commonly 1-6 years, 6-12 years and 12-15 years. For safety reasons and simplicity, the investigators want to start with the two older groups. The investigators will treat the participants with two antiviral medications (Pleconaril and ribavirin) or placebo in a double blind, randomized, placebo controlled, parallel group study. Pleconaril has previously been given in doses of 5-10mg/kg x 2-3 in clinical trials in children, thus achieving serum levels high enough for killing the majority of the viruses. The investigators have, due to the long treatment period, reduced the doses to 5 mg/kg x 2. Ribavirin will be given in dosages according to Summariy of product characteristics (SmPC). The investigators have chosen to administer Investigational Medicinal Product (IMPs) as an oral solution as this will make it easier to give the medication according to weight.

Being tested
Ribavirin + Pleconaril, Placebos
Keywords
Type 1 diabetes, Children, Enterovirus, Recent onset
Medical subject headings
Enterovirus Infections, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ribavirin + PleconarilDrug

    Randomized to treatment with study drugs (ribavirin and pleconaril)

  • PlacebosDrug

    Randomized to treatment with placebo

Study groups in NCT04838145
Study groupRoleWhat they receive
Active treatmentActive comparatorPleconaril: 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.
Receives: Drug: Ribavirin + Pleconaril
PlaceboPlacebo comparatorReceives placebo, on a double blind basis
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (12)

  1. Insulin secretion

    Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 3 months after initiation of study treatment.

    Measured: 3 months

  2. Insulin secretion

    Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 6 months after initiation of study treatment.

    Measured: 6 months

  3. Insulin secretion

    Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 24 months after initiation of study treatment.

    Measured: 24 months

  4. Insulin secretion

    Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 36 months after initiation of study treatment.

    Measured: 36 months

  5. Stimulated c-peptide

    Proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide >0.2 pmol/L

    Measured: 36 months

  6. C-peptide filter paper

    Fasting and meal stimulated C-peptide from blood sampled on filter paper at home at 4 weekly intervals throughout the study period

    Measured: 36 months

  7. Insulin dose

    Mean Insulin dosage per kilo bodyweight per 24 hours

    Measured: 36 months

  8. HbA1c

    HbA1c at every control

    Measured: 36 months

  9. Hypoglycemic events

    Number of severe hypoglycaemic events and less severe events requiring assistance from others with blood glucose values ≤ 3.9 mmol/L will be registered at each control

    Measured: 36 months

  10. Insulin-dose-adjusted HbA1c (IDAA1c)

    HbA1c adjusted to insulin dose

    Measured: 36 months

  11. Proinsulin/c-peptide ratio in serum

    Proinsulin/c-peptide ratio in serum as a measure of beta cell stress

    Measured: 36 months

  12. Presence of enterovirus

    Presence of enterovirus and rhinovirus and/or neutralizing antibodies against those viruses in nose, blood, saliva and stool

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start30 Aug 2018
  3. Primary completion25 Oct 2020
  4. Study completion25 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind, placebo controlled, prospective, randomized trial examining the effect of antiviral treatment given for 6months on residual insulin secretion
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04838145
Sponsor's protocol ID
2015-003350-41
Other IDs
2015
Acronym
DiViDInt
Status last verified
Apr 2021
First submitted
4 Jan 2019
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data and material collected from the placebo-group will be shared with the "Innodia" consortium

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribavirin + Pleconaril in people with Type1 Diabetes Mellitus and Enterovirus, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin secretion (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04838145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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