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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

NCT ID: NCT01868568

Last Updated: 2015-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IDegAsp 30 + placebo

Group Type EXPERIMENTAL

insulin degludec/insulin aspart 30

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Insulin aspart + insulin degludec - low concentration 1

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

IDegAsp 40 + placebo

Group Type EXPERIMENTAL

insulin degludec/insulin aspart 40

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Insulin aspart + insulin degludec - high concentration 1

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

IDegAsp 45 + placebo

Group Type EXPERIMENTAL

insulin degludec/insulin aspart 45

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Insulin aspart + insulin degludec

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

IDegAsp 55 + placebo

Group Type EXPERIMENTAL

insulin degludec/insulin aspart 55

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Insulin aspart + insulin degludec - high concentration

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

insulin aspart

Intervention Type DRUG

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

BIAsp 30 + placebo

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

Interventions

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insulin degludec

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

Intervention Type DRUG

insulin degludec/insulin aspart 30

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

Intervention Type DRUG

insulin degludec/insulin aspart 40

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

Intervention Type DRUG

insulin degludec/insulin aspart 45

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

Intervention Type DRUG

insulin degludec/insulin aspart 55

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

Intervention Type DRUG

insulin aspart

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

Intervention Type DRUG

biphasic insulin aspart 30

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
* Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)

Exclusion Criteria

* A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator
* A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
* A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Neuss, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2007-006110-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN5401-1959

Identifier Type: -

Identifier Source: org_study_id

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