NCT03352674

Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients

Detailed description

Previous study has revealed that Insulin Glargine (Kalbe Farma) has similar efficacy with Lantus (Sanofi-Aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. Therefore, the present study is aiming to compare immunogenicity of Insulin Glargine (Kalbe Farma) and Lantus (Sanofi-Aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin Glargine Ezelin	Insulin Glargine (Ezelin) once daily at individually adjusted dose
DRUG	Insulin Glargine Pen Injector [Lantus]	Insulin Glargine (Lantus) once daily at individually adjusted dose

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-11-24
• Last updated: 2020-04-01

Locations

1 site across 1 country: Indonesia