Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
ConditionType 1 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-34
SponsorSanofi
About this trial
This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment.
Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.
Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.
Eligibility criteria
Qualifiers
Male or female Japanese participant, 1 (inclusive) to 34 years (inclusive) of age, at the time of signing the informed consent. Japanese: born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.
Participant is positive for 2 or more T1D related auto-antibodies (confirmed by written medical history and/or obtained at study screening). The autoantibodies that are to be confirmed are anti-GAD (glutamic acid decarboxylase), anti-IA2 (insulinoma-associated antigen 2), anti-insulin, anti-ZnT8 (zinc transporter 8), and/or ICA (islet cell antibody).
Oral glucose tolerance test (OGTT) or blood HbA1c confirms the participant has dysglycemia without overt hyperglycemia.
Participant must be in good health (except for being Stage 2 T1D) as determined by medical e)valuation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) XE " ECG " \f Abbreviation \t "electrocardiogram" .
Disqualifiers
None
Trial design
Treatments tested in this trial
- Teplizumab
Treatment groups
10 Participants
are divided into 2 treatment groupsLocations
11Investigational Site Number : 3920015272-0827, IchikawaChiba, Japan
Investigational Site Number : 3920006060-8543, SapporoHokkaido, Japan
Investigational Site Number : 3920018650-0017, KobeHyōgo, Japan
Investigational Site Number : 3920007028-3695, YahabaIwate, Japan
Sponsors and collaborators
Sanofi
Lead sponsor
Source ClinicalTrials.gov