NCT01353833

Brief Summary

IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The investigators recently showed that low dose IL-2 is well tolerated in patients with an autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg induction, the investigators aim to protect the remaining/regenerating β-cells from autoimmune destruction, thus improving or even curing T1D.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 23, 2012

Status Verified

May 1, 2011

Enrollment Period

5 months

First QC Date

May 12, 2011

Last Update Submit

April 20, 2012

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Kinetic parameters of Treg proportions variation within CD4+ T cells in peripheral blood

    from Day+0 to Day+60

Secondary Outcomes (1)

  • Improvement of residual secretion of insulin assessed by the AUC of peptide C during a standardized test meal in IL-2 vs placebo treated patients

    at Day+0 and Day+60

Study Arms (4)

IL2-4

PLACEBO COMPARATOR
Drug: Aldesleukin

IL2-2

EXPERIMENTAL

1 millions IU of IL-2 per day

Drug: Aldesleukin

IL2-3

EXPERIMENTAL

3 millions IU of IL-2 per day

Drug: Aldesleukin

IL2-1

EXPERIMENTAL

0.33 millions IU of IL-2 per day

Drug: Aldesleukin

Interventions

AldesleukinDRUG

0.33 ; 1 ; 3 ; 0 millions IU of IL-2 per day for arm 1 to 4, respectively. 1 s.c. injection per day for 5 days.

Also known as: IL2
IL2-1IL2-2IL2-3IL2-4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \[18-50\] years;
  • With a T1D:
  • Treated with insulin for ≤ 2 years,
  • With at least one auto-antibody among: anti-islet, anti-GAD, anti-IA2, anti-ZnT8 ;
  • No clinically relevant abnormal value for hematology, biochemistry, liver and kidney function
  • Lymphocyte \[1000-4000\]/ mm3
  • Informed consent signed by the patient and the investigator before any intervention necessary for the trial.

You may not qualify if:

  • Contra-indications to IL2 :
  • Hypersensibility to IL-2 or its excipients,
  • Severe cardiopathy
  • Ongoing infection requiring antibiotherapy,
  • O2 Saturation ≤ 90 %
  • Severe impairment of a vital organ
  • Previous organ allograft
  • Non authorized concomitant treatment : i.e. immuno-modulators, cytotoxic, drug modifying glycemia
  • Cancer progressing or cured for less than 5 years except for primary basal cell carcinoma or carcinoma in situ of the uterine cervix.
  • Participation to another clinical investigation in \< 3 months
  • Pregnant or lactating women
  • Male or female in age of procreation without efficient contraception during the study
  • No affiliation to National Health Insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • Hartemann A, Bensimon G, Payan CA, Jacqueminet S, Bourron O, Nicolas N, Fonfrede M, Rosenzwajg M, Bernard C, Klatzmann D. Low-dose interleukin 2 in patients with type 1 diabetes: a phase 1/2 randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):295-305. doi: 10.1016/S2213-8587(13)70113-X. Epub 2013 Oct 8.

    PMID: 24622415DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

aldesleukinInterleukin-2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Davis Klatzmann, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

April 1, 2012

Last Updated

April 23, 2012

Record last verified: 2011-05

Locations

FR(1)