• Credits
  • Section Writer: Dr. Om J Lakhani
  • Section Editor: Dr. Om J Lakhani

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• Q. What are the potential immune-modulatory therapies currently tried in patients with Type 1 Diabetes?
  • 1. Anti-CD3 monoclonal antibody - Teplizumab in Type 1 Diabetes 1
  • 2. Low-dose thymocyte globulin
  • 3. abatacept
  • 
• Q. What are the stages of Type 1 Diabetes?
  • 
• Q. What is Stage 1 of Type 1 Diabetes?
  • It is when two or more antibodies are positive but the patient is asymptomatic or presymptomatic for Type 1 Diabetes and has normal glucose levels
  • The antibodies are :
    • GAD65 antibody
    • Znt8
    • IA-2
• Q. What is Stage 2 of Type 1 Diabetes?
  • This is when a patient has
    • Antibodies positive (2 or more)
    • Glucose and HbA1c are in the Prediabetes range
    • Patient is per se presymptomatic or asymptomatic
• Q. What is stage 3 of Type 1 Diabetes?
  • Full-blown type 1 diabetes with symptoms
• Q. What is the probability of stage 2 type 1 diabetes developing full-blown type 1 diabetes (Stage 3)?
  • 60% in 2 years
  • 75% in 4-5 years
• Q. What is Teplizumab in Type 1 Diabetes?
  • It is a monoclonal anti-CD3 nonbinding antibody
• Q. What is its role in Type 1 Diabetes?
  • It delays the conversion of Stage 2 of type 1 diabetes to stage 2
• Q. Teplizumab in Type 1 Diabetes 1 received approval based on which study?
  • Based on study by Harold et al published in 2019^[1]
• Q. How was the drug given in this study?
  • Daily infusion for 14 days
• Q. How long were the patients followed?
  • For 51 months
• Q. How was the progression in the drug versus placebo group?
  • The time to diagnosis of type 1 in the placebo group was 24 months
  • It was 48 months in the treatment group
  • Type 1 developed in 43% of patients on the drug and 72% of patients on a placebo
• Q. What is the potential adverse effect of the drug?
  • Lymphopenia
• Q. What was the Protégé study and what were their results?
  • This study was published in Lancet in 2011 in which they study the effect of Teplizumab in Type 1 Diabetes 1 in newly diagnosed type 1 diabetes (within 12 weeks of diagnosis)
  • Different doses and regimens of the drug were studied
  • Overall there was no impact on the primary outcomes in the various groups who were studied - there was no significant beta-cell preservation
  • However, a small subgroup did benefit more than others
  • They were those who were
    • Treated within 6 weeks of diagnosis
    • Had C-peptide mean AUC >0.2
    • HBA1c <7.5%
    • Insulin requirement <0.4 units/kg/day
    • Age of 8-17 years
  • Hence probably it is more useful if given very early in the course of the disease^[2]
  • Another study (ABATE study) use the drug in newly diagnosed type 1 diabetes within 8 weeks of diagnosis. Over a longer period, though HBA1c in the two groups was similar, the patients who receive Teplizumab in Type 1 Diabetes 1 had lesser insulin requirement and better beta-cell preservation^[3]
• Q. Which is another drug in the same group which is being tried?
  • Otelixizumab
  • It is showing promising results in some recent trials