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A Trial Investigating NN1218 in Subjects With Type 1 Diabetes

NCT ID: NCT01121289

Last Updated: 2013-12-10

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 diabetes.

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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NN1218, formulation A

Group Type EXPERIMENTAL

NN1218

Intervention Type DRUG

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

NN1218, formulation B

Group Type EXPERIMENTAL

NN1218

Intervention Type DRUG

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

NN1218, formulation B (high)

Group Type EXPERIMENTAL

NN1218

Intervention Type DRUG

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

NN1218, formulation C

Group Type EXPERIMENTAL

NN1218

Intervention Type DRUG

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

NN1218, formulation D

Group Type EXPERIMENTAL

NN1218

Intervention Type DRUG

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

insulin aspart

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

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

Interventions

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NN1218

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

Intervention Type DRUG

insulin aspart

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

Intervention Type DRUG

NN1218

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

Intervention Type DRUG

NN1218

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

Intervention Type DRUG

NN1218

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

Intervention Type DRUG

NN1218

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
* Body mass index (BMI) between 18.0-28.0 kg/m2 (both inclusive)

Exclusion Criteria

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* 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

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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U1111-1113-6955

Identifier Type: OTHER

Identifier Source: secondary_id

2009-017121-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1218-3808

Identifier Type: -

Identifier Source: org_study_id