Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

NCT ID: NCT00600626

Last Updated: 2017-01-06

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

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-07-31

Brief Summary

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This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in 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

Interventions

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biphasic insulin aspart

Intervention Type DRUG

insulin NPH

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
* HbA1c between 8.0-10.5%
* Body mass index (BMI) below 35.0 kg/m2
* Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria

* Total daily insulin dose of 1.80 IU/kg or more
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
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

Zagreb, , Croatia

Site Status

Novo Nordisk Investigational Site

Lille, , France

Site Status

Novo Nordisk Investigational Site

Nevers, , France

Site Status

Novo Nordisk Investigational Site

Rennes, , France

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Novo Nordisk Investigational Site

Vénissieux, , France

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Novo Nordisk Investigational Site

Bad Heilbrunn, , Germany

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Novo Nordisk Investigational Site

Neuss, , Germany

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Novo Nordisk Investigational Site

Saint Ingbert, , Germany

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Novo Nordisk Investigational Site

Schaafheim, , Germany

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Novo Nordisk Investigational Site

Schwedt, , Germany

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Novo Nordisk Investigational Site

Völklingen, , Germany

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Novo Nordisk Investigational Site

Wiesbaden, , Germany

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Novo Nordisk Investigational Site

Würzburg, , Germany

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Novo Nordisk Investigational Site

Shatin, New Territories, , Hong Kong

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Novo Nordisk Investigational Site

Cheras, , Malaysia

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Novo Nordisk Investigational Site

Kota Bharu, Kelantan, , Malaysia

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Novo Nordisk Investigational Site

Beverwijk, , Netherlands

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Novo Nordisk Investigational Site

Delft, , Netherlands

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Novo Nordisk Investigational Site

Eindhoven, , Netherlands

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Novo Nordisk Investigational Site

Rotterdam, , Netherlands

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Novo Nordisk Investigational Site

Lodz, , Poland

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Novo Nordisk Investigational Site

Lublin, , Poland

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Novo Nordisk Investigational Site

Szczecin, , Poland

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Novo Nordisk Investigational Site

Warsaw, , Poland

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Novo Nordisk Investigational Site

Zabrze, , Poland

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Novo Nordisk Investigational Site

Cluj-Napoca, Cluj, Romania

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Novo Nordisk Investigational Site

Constanța, , Romania

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Novo Nordisk Investigational Site

Iași, , Romania

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Novo Nordisk Investigational Site

Timișoara, , Romania

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Novo Nordisk Investigational Site

Moscow, , Russia

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Novo Nordisk Investigational Site

Moscow, , Russia

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Novo Nordisk Investigational Site

Saint Petersburg, , Russia

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Novo Nordisk Investigational Site

Saint Petersburg, , Russia

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Novo Nordisk Investigational Site

Singapore, , Singapore

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Novo Nordisk Investigational Site

Córdoba, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Orihuela, , Spain

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Novo Nordisk Investigational Site

Sabadell, , Spain

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Novo Nordisk Investigational Site

Seville, , Spain

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Novo Nordisk Investigational Site

Seville, , Spain

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Novo Nordisk Investigational Site

Valladolid, , Spain

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Novo Nordisk Investigational Site

Falun, , Sweden

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Novo Nordisk Investigational Site

Gothenburg, , Sweden

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Novo Nordisk Investigational Site

Linköping, , Sweden

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Novo Nordisk Investigational Site

Lund, , Sweden

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Novo Nordisk Investigational Site

Mölndal, , Sweden

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Novo Nordisk Investigational Site

Uppsala, , Sweden

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Novo Nordisk Investigational Site

Bradford, , United Kingdom

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Novo Nordisk Investigational Site

Brighton, , United Kingdom

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Novo Nordisk Investigational Site

Coventry, , United Kingdom

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Novo Nordisk Investigational Site

Edinburgh, , United Kingdom

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Novo Nordisk Investigational Site

Glasgow, , United Kingdom

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Novo Nordisk Investigational Site

Northampton, , United Kingdom

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Novo Nordisk Investigational Site

Plymouth, , United Kingdom

Site Status

Novo Nordisk Investigational Site

York, , United Kingdom

Site Status

Countries

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Croatia France Germany Hong Kong Malaysia Netherlands Poland Romania Russia Singapore Spain Sweden United Kingdom

References

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Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.

Reference Type RESULT
PMID: 17115349 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-1486

Identifier Type: -

Identifier Source: org_study_id

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