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Type 1 DiabetesPhase 2DFIL2-ChildNCT01862120

Dose Finding Study of Il-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes

A Phase 2 study testing Dose D1 of interleukin-2, Dose D2 of Interleukin-2 and Dose D3 of interleukin-2 in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

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

Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key role in the regulation of the immune system. At high doses, rhIL-2 activates the immune effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells (TREGS), a population of immune cells… Read more about this study

Who is it for?
Ages 7 to 14 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Dose D1 of interleukin-2, Dose D2 of Interleukin-2 and Dose D3 of interleukin-2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
6 sitesFrance
Study dates
27 Jun 2013to 16 Mar 2017
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 7 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age [7-13] years for girls and [7-14] years for boys
  • With a T1D diagnosis (as ADA)
  • Treated with insulin for ≤ 3 months,
  • With at least one auto-antibody among: anti-insulin, anti-GAD, anti-IA2, anti-ZnT8 ;
  • No clinically relevant abnormal findings for haematology, biochemistry, liver and kidney functions
  • Informed consent signed by the patient, the parents, and the investigator before any intervention necessary for the trial.

Who cannot join

  • Contra-indications to IL-2 :
  • Hyper sensibility to IL-2 or its excipients,
  • Severe cardiopathy
  • Previous organ allograft
  • Ongoing infection requiring antibiotherapy,
  • O2 Saturation ≤ 90 %
Show all 20Show fewer
  • Severe impairment of any vital organ
  • Documented history of other auto-immune diseases (except for auto-antibodies for, IAA, GADA, IA-2A, anti-ZnT8A, and stable thyroiditis with normal TSH (<10 mUI/L), T3 and, T4 levels.
  • Diabetes onset characteristics including:
  • Continuous nocturnal polyuria ≥ 3 months ;
  • Inaugural acidosis (with venous Ph < 7.25) ;
  • HbA1c at diagnostic ≥ 13%;
  • Weight loss ≥ 10 % at diagnosis ;
  • Positive autoantibodies to 21-hydroxylase
  • Stage 2 obesity
  • Non authorized concomitant treatment : immuno-modulators, cytotoxic drugs, drug modifying plasma glycemia
  • vaccination ≤ 4 weeks with life vaccin
  • Positive serology (IgM) to the Epstein-Barr virus (EBV) and/or cytomegalovirus (CMV), reflecting an acute infection.
  • Participation to another clinical investigation in previous 3 months
  • No affiliation to National Health Insurance

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Service d'Endocrinologie Pédiatrique

    Le Kremlin-Bicêtre, 94275

  • Service de Pédiatrie - CHU de Nîmes

    Nîmes, 30029 cedex 9

  • CIC pédiatrique - CHU de Necker

    Paris, 75015

  • Service d'endocrinologie pédiatrique - CHU de Necker

    Paris, 75015

  • CIC 9202 CHU Rober Débré

    Paris, 75019

  • Service d'endocrinologie Diabétologie pédiatrique CHU Robert Débré

    Paris, 75019

Other trials in France

About this study

Official title: Induction of Regulatory T Cells for the Treatment of Recently Diagnosed Type 1 Diabetes: Dose Finding Study of the Lowest Active Dose of IL-2 in Children

Human recombinant interleukin-2 (rhIL-2) is a biological signalling protein playing a key role in the regulation of the immune system. At high doses, rhIL-2 activates the immune effectors T cells (TEFFS) while at low doses rhIL-2 induces and activates regulatory T cells (TREGS), a population of immune cells controlling the immune Teff response. In patients with Type 1 Diabetes (T1D), TREGS fail to control the autoimmune destruction by TEFFS of pancreatic beta-cells producing insulin. The investigator recently showed that rhIL-2 at low dose is well tolerated in patients with an autoimmune disease and in adults with established T1D, inducing TREGS without effects on TEFFS. The investigators aim to use rhIL-2 at low dose to induce/stimulate TREGS in young recently diagnosed T1D patients. This study will investigate the dose effect relationship of low dose rhIL-2 on TREG induction such as to optimize the risk benefit ratio of this treatment in T1D. Through Treg induction, the investigators aim to protect the remaining/regenerating pancreatic β-cells from autoimmune destruction, thus improving or even curing T1D.

Read the detailed description

Main objective:

Define the lowest dose of rhIL-2 inducing TREGS in children with recently diagnosed type 1 diabetes.

Conduct of the study:

Three doses will be studied versus placebo in parallel groups of six patients. Each dose or placebo will be studied according to three periods of treatment:

  1. Induction of TREGS following a cure of 5 days repeated once daily administration [day 1 - day 5].
  2. Maintenance of TREGS following repeated administration once every two weeks for one year [day 15 - day 337].

At each treatment period, Treg response and tolerance will be evaluated. In addition, overall response on T1D parameters will be assessed throughout the study.

Conditions
Type 1 Diabetes
Being tested
Dose D1 of interleukin-2, placebo, Dose D2 of Interleukin-2, Dose D3 of interleukin-2
Keywords
Recently diagnosed, Regulatory T Cells, Tolerance Induction, Paediatrics, Low dose, IL-2
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • Dose D1 of interleukin-2Drug

    subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

  • placeboDrug

    subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

  • Dose D2 of Interleukin-2Drug

    subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

  • Dose D3 of interleukin-2Drug

    subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).

Study groups in NCT01862120
Study groupRoleWhat they receive
interleukin-2ExperimentalDose D1 of interleukin-2
Receives: Drug: Dose D1 of interleukin-2
Dose D2 of interleukin-2ExperimentalDose D2 of interleukin-2
Receives: Drug: Dose D2 of Interleukin-2
Dose D3 of interleukin-2ExperimentalDose D3 of interleukin-2
Receives: Drug: Dose D3 of interleukin-2
placeboPlacebo comparatorplacebo
Receives: Drug: placebo

What is being measured

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

  1. Treg response following the induction cure period

    expressed as % total CD4 cells

    Measured: day 5

Secondary outcomes (6)

  1. Fasting plasma concentration of C-peptide

    Measured: at Day 0, 99, 183, 267, 351, 436

  2. C-peptide AUC response to a mixed meal tolerance test

    Measured: at baseline, at months 6, 12, 15

  3. IDAA1C score

    is a score defined as A1C (percent) + [4 x insulin dose (units per kilogram per 24 h)] without unit

    Measured: at baseline, at months 3, 6, 9, 12, 15

  4. HbA1c

    Measured: at baseline, at months 3, 6, 9, 12, 15

  5. Treg response after the last administration

    Measured: day 351, day 436

  6. Treg response during the maintenance period compare to the baseline

    Treg response expressed as the % / CD4 will be measured several times

    Measured: day 15, day 29, day 43, day 99, day 183, day 267

Timeline

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

  1. First posted24 May 2013 (estimated)
  2. Study start27 Jun 2013
  3. Primary completion8 Jul 2016
  4. Study completion16 Mar 2017

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
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01862120
Sponsor's protocol ID
P101106
Acronym
DFIL2-Child
Status last verified
Nov 2020
First submitted
10 Dec 2012
Last updated
12 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Rosenzwajg M, Salet R, Lorenzon R, Tchitchek N, Roux A, Bernard C, Carel JC, Storey C, Polak M, Beltrand J, Amouyal C, Hartemann A, Corbeau P, Vicaut E, Bibal C, Bougneres P, Tran TA, Klatzmann D. Low-dose IL-2 in children with recently diagnosed type 1 diabetes: a Phase I/II randomised, double-blind, placebo-controlled, dose-finding study. Diabetologia. 2020 Sep;63(9):1808-1821. doi: 10.1007/s00125-020-05200-w. Epub 2020 Jul 1.

    PubMed 32607749

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dose D1 of interleukin-2, Dose D2 of Interleukin-2 and Dose D3 of interleukin-2 in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.

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 6 inclusion and 20 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 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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?

Treg response following the induction cure period (time frame: day 5). 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 NCT01862120, which also lists 1 linked publication.

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 12 Nov 2020.

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