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Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

NCT01868568 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-10-22

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.

Conditions

Interventions

DRUG

insulin degludec

Administered subcutaneously (s.c., under the skin).

DRUG

insulin degludec/insulin aspart 30

A single dose administered subcutaneously (s.c., under the skin).

DRUG

insulin degludec/insulin aspart 40

A single dose administered subcutaneously (s.c., under the skin).

DRUG

insulin degludec/insulin aspart 45

A single dose administered subcutaneously (s.c., under the skin).

DRUG

insulin degludec/insulin aspart 55

A single dose administered subcutaneously (s.c., under the skin).

DRUG

insulin aspart

A single dose administered subcutaneously (s.c., under the skin).

DRUG

biphasic insulin aspart 30

A single dose administered subcutaneously (s.c., under the skin).

DRUG

placebo

A single dose administered subcutaneously (s.c., 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
2008-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01868568 on ClinicalTrials.gov