NCT01865279View on ClinicalTrials.gov

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

April 30, 2006

Study Completion Date

April 30, 2006

Conditions
DiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Interventions
DRUG

insulin degludec

Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.

DRUG

placebo

Ascending single doses - 5 dose levels

DRUG

insulin degludec

A single dose corresponding to that of isophane human insulin

DRUG

isophane human insulin

A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes

Trial Locations (1)

41460

Neuss

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01865279 - Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin Degludec | Biotech Hunter | Biotech Hunter