Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

NCT ID: NCT00604656

Last Updated: 2017-03-01

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

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-05

Study Completion Date

2004-01-29

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin aspart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with type 1 diabetes
* Duration of diabetes for at least 12 months
* Treatment with insulin aspart for at least 3 months before trial start
* Body Mass Index (BMI) below 35.0 kg/m2
* HbA1c below 12.0%

Exclusion Criteria

* Total insulin dosage more than 1.4 IU/kg/day
* Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
* Known hypoglycaemia unawareness as judged by the investigator
* Known hypersensitivity or allergy
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

Hradec Králové, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Bad Kreuznach, , Germany

Site Status

Novo Nordisk Investigational Site

Bad Neuenahr-Ahrweiler, , Germany

Site Status

Novo Nordisk Investigational Site

Diez, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt, , Germany

Site Status

Novo Nordisk Investigational Site

Friedrichsthal, , Germany

Site Status

Novo Nordisk Investigational Site

Karlsruhe, , Germany

Site Status

Novo Nordisk Investigational Site

Marktheidenfeld, , Germany

Site Status

Novo Nordisk Investigational Site

Marl, , Germany

Site Status

Novo Nordisk Investigational Site

Oberursel, , Germany

Site Status

Novo Nordisk Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

Novo Nordisk Investigational Site

Saarbrücken, , Germany

Site Status

Novo Nordisk Investigational Site

Saint Ingbert, , Germany

Site Status

Novo Nordisk Investigational Site

Simmern, , Germany

Site Status

Novo Nordisk Investigational Site

Speyer, , Germany

Site Status

Novo Nordisk Investigational Site

Würzburg, , Germany

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Nyíregyháza, , Hungary

Site Status

Novo Nordisk Investigational Site

Cagliari, , Italy

Site Status

Novo Nordisk Investigational Site

Chiavari, , Italy

Site Status

Novo Nordisk Investigational Site

Città di Castello, , Italy

Site Status

Novo Nordisk Investigational Site

Lucca, , Italy

Site Status

Novo Nordisk Investigational Site

Orvieto, , Italy

Site Status

Novo Nordisk Investigational Site

Parma, , Italy

Site Status

Novo Nordisk Investigational Site

Perugia, , Italy

Site Status

Novo Nordisk Investigational Site

Rimini, , Italy

Site Status

Novo Nordisk Investigational Site

Roma, , Italy

Site Status

Novo Nordisk Investigational Site

Roma, , Italy

Site Status

Novo Nordisk Investigational Site

Bytom, , Poland

Site Status

Novo Nordisk Investigational Site

Mazowieckie, , Poland

Site Status

Novo Nordisk Investigational Site

Radom, , Poland

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Wroclaw, , Poland

Site Status

Countries

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Czechia Germany Hungary Italy Poland

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN2000-1542

Identifier Type: -

Identifier Source: org_study_id

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