MedTrace Logo

Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

NCT00993096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-02-10

No results posted yet for this study

Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Conditions

Interventions

DRUG

insulin degludec/insulin aspart

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

DRUG

insulin degludec/insulin aspart

Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)

DRUG

insulin degludec/insulin aspart

Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

DRUG

biphasic insulin aspart 30

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

DRUG

biphasic insulin aspart 30

Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)

DRUG

biphasic insulin aspart 30

Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993096 on ClinicalTrials.gov