The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin® Log-G With Its Reference Lantus® in Patients With Type 2 Diabetes Mellitus

NCT04591457 Phase 2 UNKNOWN

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

Details

Lead sponsor	Indonesia University
Phase	Phase 2
Status	UNKNOWN
Enrolment	120
Start date	2020-10
Completion	2021-08

Conditions

• Diabetes Mellitus

Interventions

• Insulin Glargine Sansulin
• Insulin Glargine Pen Injector [Lantus]

Primary outcomes

• HbA1c — 24 weeks
  Change in HbA1c level after 24 weeks of therapy compared to baseline value
• Number of patients — 24 weeks
  Number of patients with HbA1c \< 7%
• Anti-insulin antibodies (AIAs) — 24 weeks
  Change in anti-insulin antibodies (AIAs) after 24 weeks of therapy compared to baseline value

Countries

Indonesia