Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes

NCT ID: NCT01467401

Last Updated: 2017-02-24

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

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-19

Study Completion Date

2003-05-15

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of biphasic insulin aspart (NovoMix®30) to that of biphasic human insulin (Mixtard® 30) 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

biphasic insulin aspart

Intervention Type DRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

B

Group Type ACTIVE_COMPARATOR

biphasic human insulin

Intervention Type DRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

Interventions

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biphasic insulin aspart

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

Intervention Type DRUG

biphasic human insulin

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes for at least 24 months
* Insulin treatment for the pase 3 months
* HbA1c (glycosylated haemoglobin) below 13%
* BMI (Body Mass Index) below 40 kg/m\^2
* Ability and willingness to perform self-blood glucose monitoring

Exclusion Criteria

* Receipt of any investigational drug within 4 weeks prior to this trial
* Treatment of OHAs (Oral Hypoglycaemic Agents) within 4 weeks prior to this trial
* Total daily insulin dosage less than or equal to 1.8 IU/kg
Minimum Eligible Age

18 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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Novo Nordisk Investigational Site

Århus C, , Denmark

Site Status

Novo Nordisk Investigational Site

Esbjerg, , Denmark

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Novo Nordisk Investigational Site

Herning, , Denmark

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Novo Nordisk Investigational Site

Holbæk, , Denmark

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Novo Nordisk Investigational Site

Næstved, , Denmark

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Novo Nordisk Investigational Site

Randers, , Denmark

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Novo Nordisk Investigational Site

Silkeborg, , Denmark

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Novo Nordisk Investigational Site

Skive, , Denmark

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Novo Nordisk Investigational Site

Viborg, , Denmark

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Novo Nordisk Investigational Site

Åsgårdstrand, , Norway

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Novo Nordisk Investigational Site

Bekkestua, , Norway

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Novo Nordisk Investigational Site

Bergen, , Norway

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Novo Nordisk Investigational Site

Haugesund, , Norway

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Novo Nordisk Investigational Site

Hønefoss, , Norway

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Novo Nordisk Investigational Site

Moelv, , Norway

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Novo Nordisk Investigational Site

Oslo, , Norway

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Novo Nordisk Investigational Site

Tromsø, , Norway

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Novo Nordisk Investigational Site

Vennesla, , Norway

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Novo Nordisk Investigational Site

Arvika, , Sweden

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Novo Nordisk Investigational Site

Avesta, , Sweden

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Novo Nordisk Investigational Site

Bjuv, , Sweden

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Novo Nordisk Investigational Site

Broby, , Sweden

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Novo Nordisk Investigational Site

Färgelanda, , Sweden

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Novo Nordisk Investigational Site

Gothenburg, , Sweden

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Novo Nordisk Investigational Site

Gothenburg, , Sweden

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Novo Nordisk Investigational Site

Gothenburg, , Sweden

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Novo Nordisk Investigational Site

Gothenburg, , Sweden

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Novo Nordisk Investigational Site

Grästorp, , Sweden

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Novo Nordisk Investigational Site

Habo, , Sweden

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Novo Nordisk Investigational Site

Härnösand, , Sweden

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Novo Nordisk Investigational Site

Hässleholm, , Sweden

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Novo Nordisk Investigational Site

Helsingborg, , Sweden

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Novo Nordisk Investigational Site

Jönköping, , Sweden

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Novo Nordisk Investigational Site

Karlstad, , Sweden

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Novo Nordisk Investigational Site

Karlstad, , Sweden

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Novo Nordisk Investigational Site

Kristianstad, , Sweden

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Novo Nordisk Investigational Site

Kristinehamn, , Sweden

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Novo Nordisk Investigational Site

Kungsbacka, , Sweden

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Novo Nordisk Investigational Site

Malmo, , Sweden

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Novo Nordisk Investigational Site

Mellerud, , Sweden

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Novo Nordisk Investigational Site

Mölndal, , Sweden

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Novo Nordisk Investigational Site

Norrköping, , Sweden

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Novo Nordisk Investigational Site

Örebro, , Sweden

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Novo Nordisk Investigational Site

Örebro, , Sweden

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Novo Nordisk Investigational Site

Örebro, , Sweden

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Novo Nordisk Investigational Site

Östersund, , Sweden

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Novo Nordisk Investigational Site

Östersund, , Sweden

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Novo Nordisk Investigational Site

Säffle, , Sweden

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Novo Nordisk Investigational Site

Skövde, , Sweden

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Novo Nordisk Investigational Site

Stockholm, , Sweden

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Novo Nordisk Investigational Site

Tomelilla, , Sweden

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Novo Nordisk Investigational Site

Torsby, , Sweden

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Novo Nordisk Investigational Site

Trollhättan, , Sweden

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Novo Nordisk Investigational Site

Trollhättan, , Sweden

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Novo Nordisk Investigational Site

Tyresö, , Sweden

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Novo Nordisk Investigational Site

Uddevalla, , Sweden

Site Status

Novo Nordisk Investigational Site

Värnamo, , Sweden

Site Status

Countries

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Denmark Norway Sweden

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-1394

Identifier Type: -

Identifier Source: org_study_id

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