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Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

NCT ID: NCT01649570

Last Updated: 2012-07-25

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

PHASE4

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2003-08-31

Brief Summary

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This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin aspart

Group Type EXPERIMENTAL

insulin aspart

Intervention Type DRUG

Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks

Interventions

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insulin aspart

Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
* HbA1c below or equal to 11.0%
* BMI (body mass index) below 30 kg/m\^2
Minimum Eligible Age

20 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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Novo Nordisk A/S

Principal Investigators

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Henning Andersen

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-1472

Identifier Type: -

Identifier Source: org_study_id