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A Trial Investigating the Effect of NN5401 in Subjects With Type 2 Diabetes

NCT ID: NCT01134224

Last Updated: 2013-11-27

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with type 2 diabetes.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

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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NN5401 - low dose

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

0.4 U/kg body weight injected subcutaneously (under the skin) once

NN5401 - medium dose

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

0.6 U/kg body weight injected subcutaneously (under the skin) once

NN5401 - high dose

Group Type EXPERIMENTAL

insulin degludec/insulin aspart

Intervention Type DRUG

0.8 U/kg body weight injected subcutaneously (under the skin) once

biphasic insulin aspart 30 - low dose

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

0.4 U/kg body weight injected subcutaneously (under the skin) once

biphasic insulin aspart 30 - medium dose

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

0.6 U/kg body weight injected subcutaneously (under the skin) once

biphasic insulin aspart 30 - high dose

Group Type ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type DRUG

0.8 U/kg body weight injected subcutaneously (under the skin) once

Interventions

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biphasic insulin aspart 30

0.4 U/kg body weight injected subcutaneously (under the skin) once

Intervention Type DRUG

biphasic insulin aspart 30

0.6 U/kg body weight injected subcutaneously (under the skin) once

Intervention Type DRUG

biphasic insulin aspart 30

0.8 U/kg body weight injected subcutaneously (under the skin) once

Intervention Type DRUG

insulin degludec/insulin aspart

0.4 U/kg body weight injected subcutaneously (under the skin) once

Intervention Type DRUG

insulin degludec/insulin aspart

0.6 U/kg body weight injected subcutaneously (under the skin) once

Intervention Type DRUG

insulin degludec/insulin aspart

0.8 U/kg body weight injected subcutaneously (under the skin) once

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index below or equal to 35.0 kg/m\^2

Exclusion Criteria

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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U1111-1113-7056

Identifier Type: OTHER

Identifier Source: secondary_id

2009-015646-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN5401-1978

Identifier Type: -

Identifier Source: org_study_id