This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients
Sansulin® Log-G is an insulin glargine biosimilar. For a biosimilar, its efficacy, safety, and immunogenicity should be compared head-to-head with its reference product in at least non-inferiority study. Immunogenicity assessment should always be done because it is influenced by so many factors, from nature of the drug substance until patient and disease related factors. Moreover its consequences also vary considerably, from clinically irrelevant to serious and life-threatening. Immunogenicity of a biosimilar should always be investigated in humans, since animal data are usually not predictive of the immune response in humans. Since blinding of study participants is likely unfeasible, at least anti-drug antibodies should be determined in a blinded fashion. Since anti-insulin antibodies develop early, then 6 months duration of study is adequate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose
Insulin Glargine (Lantus) once daily at individually adjusted dose
Department of Internal Medicine Cipto Mangunkusumo General Hospital, Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
HbA1c
Change in HbA1c level after 24 weeks of therapy compared to baseline value
Time frame: 24 weeks
Number of patients
Number of patients with HbA1c \< 7%
Time frame: 24 weeks
Anti-insulin antibodies (AIAs)
Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value
Time frame: 24 weeks
FBG & PPBG
Change in FBG \& PPBG compared to baseline
Time frame: 24 weeks
Hypoglycemia
Incidence and severity of hypoglycemia
Time frame: 24 weeks
Weight gain
Incidence of weight gain
Time frame: 24 weeks
Adverse events
Incidence and severity of adverse events
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.