A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
DRUG

insulin degludec/insulin aspart 15

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

DRUG

insulin degludec/insulin aspart

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).

DRUG

insulin degludec

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).

DRUG

insulin aspart

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).

DRUG

placebo

Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.

Trial Locations (1)

8010

Graz

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01773798 - A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes | Biotech Hunter | Biotech Hunter