Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes

NCT ID: NCT00184561

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

PHASE4

Total Enrollment

321 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-07-31

Brief Summary

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This trial is conducted in Asia. This is a clinical trial investigating the effectiveness of using Biphasic Insulin Aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.

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

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* HbA1C = 7.5%
* Insulin naïve
* Current treatment by Oral Anti-diabetic Drugs

Exclusion Criteria

* Severe medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Guangzhou, Guangdong, China

Site Status

Novo Nordisk Investigational Site

Wuhan, Hubei, China

Site Status

Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Xi'an, Shaanxi, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Novo Nordisk Investigational Site

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

References

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Yang W, Ji Q, Zhu D, Yang J, Chen L, Liu Z, Yu D, Yan L. Biphasic insulin aspart 30 three times daily is more effective than a twice-daily regimen, without increasing hypoglycemia, in Chinese subjects with type 2 diabetes inadequately controlled on oral antidiabetes drugs. Diabetes Care. 2008 May;31(5):852-6. doi: 10.2337/dc07-1992. Epub 2008 Feb 11.

Reference Type RESULT
PMID: 18268073 (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-1707

Identifier Type: -

Identifier Source: org_study_id

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