A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

February 17, 2017

Primary Completion Date

May 3, 2017

Study Completion Date

May 3, 2017

Conditions
Type1 Diabetes Mellitus
Interventions
DRUG

Insulin glulisine (U300)

"Pharmaceutical form: solution~Route of administration: subcutaneous"

DRUG

Insulin glulisine

"Pharmaceutical form: solution~Route of administration: subcutaneous"

DRUG

Insulin aspart

"Pharmaceutical form: solution~Route of administration: intravenous/subcutaneous"

DRUG

NPH insulin

"Pharmaceutical form: solution~Route of administration: subcutaneous"

DRUG

Glucagon

"Pharmaceutical form: Powder and solvent for solution for injection~Route of administration: subcutaneous"

DRUG

Glucose

"Pharmaceutical form: solution~Route of administration: intravenous"

DRUG

Heparin

"Pharmaceutical form: solution~Route of administration: intravenous"

Trial Locations (1)

41460

Investigational Site Number 276001, Neuss

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY