Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

NCT ID: NCT01704378

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

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-18

Study Completion Date

2003-03-14

Brief Summary

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This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIAsp

Group Type EXPERIMENTAL

biphasic insulin aspart

Intervention Type DRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal

Interventions

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biphasic insulin aspart

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent obtained before any trial-related activities
* Completed the trial BIAsp-1236

Exclusion Criteria

* Planned changes in use of any prescription medication that may interfere with glucose regulation
* Known or suspected allergy to trial products or related products
* Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures
* Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator
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

Kotka, , Finland

Site Status

Novo Nordisk Investigational Site

Kuopio, , Finland

Site Status

Novo Nordisk Investigational Site

Lahti, , Finland

Site Status

Novo Nordisk Investigational Site

Gjøvik, , Norway

Site Status

Novo Nordisk Investigational Site

Horten, , Norway

Site Status

Novo Nordisk Investigational Site

Kirkenær, , Norway

Site Status

Novo Nordisk Investigational Site

Kongsvinger, , Norway

Site Status

Novo Nordisk Investigational Site

Notodden, , Norway

Site Status

Novo Nordisk Investigational Site

Falun, , Sweden

Site Status

Novo Nordisk Investigational Site

Helsingborg, , Sweden

Site Status

Novo Nordisk Investigational Site

Motala, , Sweden

Site Status

Novo Nordisk Investigational Site

Derby, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Edinburgh, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Hull, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Liverpool, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Scarborough, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Wirral, Merseyside, , United Kingdom

Site Status

Countries

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Finland Norway Sweden United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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BIASP-1386

Identifier Type: -

Identifier Source: org_study_id

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