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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Teplizumab
DrugPharmaceutical form:Solution for injection-Route of administration:Intravenous infusion
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: TeplizumabExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
Time frame
From baseline up to Week 1042
Change from baseline in area under the curve (AUC) of C-peptide
Time frame
From baseline up to Week 1043
Change from baseline in AUC of endogenous insulin
Time frame
From baseline up to Week 1044
Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test
TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event
Time frame
Throughout the study, approximately 756 daysSecondary outcomes
1
Change from baseline in fasting plasma glucose (FPG) from an oral glucose tolerance test
Time frame
From baseline up to Week 1042
Change from baseline in 2-hour plasma glucose from an oral glucose tolerance test
Time frame
From baseline up to Week 1043
Change from baseline of hemoglobin A1c (HbA1c)
Time frame
From baseline up to Week 1044
Serum concentration of teplizumab
Time frame
From Day 1 to Day 28 Source ClinicalTrials.gov