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

PHASE1CompletedINTERVENTIONAL

Enrollment

114

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

November 28, 2018

Study Completion Date

November 28, 2018

Conditions

Diabetes Mellitus, Type 1

Interventions

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.

Trial Locations (2)

Profil Institut für Stoffwechselforschung GmbH, Neuss

Profil Mainz GmbH & Co. KG, Mainz