NCT04236895

PK/PD Biosimilarity Study of Gan & Lee Insulin Glargine Injection vs.US & EU Lantus® in Type 1 Diabetes Mellitus Patients

A Glucose Clamp Trial Investigating the Biosimilarity of Gan & Lee Insulin Glargine Injection (Insulin Glargine 100 U/mL) With US and EU Lantus® Comparator Products in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Gan and Lee Pharmaceuticals, USA · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Primary objectives: To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins. max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes To demonstrate biosimilarity with regard to the total and maximum pharmacodynamic response during one dosing interval (AUC GIR.0-24h, GIR max) of Gan \& Lee Insulin Glargine with Lantus® (US RLD / EU RP) in subjects with type 1 diabetes Secondary objectives: To compare the pharmacokinetic and pharmacodynamic properties of Gan \& Lee Insulin Glargine and of Lantus® (US RLD / EU RP) To assess the safety and tolerability of Gan \& Lee Insulin Glargine and of Lantus® (US RLD / EU RP)

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Gan & Lee Insulin Glargine Injection	All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.

Timeline

• Start date: 2018-07-10
• Primary completion: 2018-11-28
• Completion: 2018-11-28
• First posted: 2020-01-22
• Last updated: 2020-01-22

Locations

2 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study