Clinical trials: Diabete Type 1

Diabetes Mellitus, Type 1

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

• Completed
• Age: 18 to 64 years
• Phase 1
• Injection or infusion

Primary objectives: To demonstrate biosimilarity with regard to the total and maximum pharmacokinetic exposure during one dosing interval (AUC ins. 0-24h, Cins.

Trial name

NCT04236895

Testing

Gan & Lee Insulin Glargine Injection

Where

2 sites in Germany

Volunteers

114 people

Sponsor

Gan and Lee Pharmaceuticals, USA