Effectiveness and Safety of Biphasic Insulin Aspart 70/30 in Subjects With Type 2 Diabetes. - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184561

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Change in HbA1c With Biphasic Insulin Aspart 70/30 in Two Different Treatment Regiments in Subjects With Type 2 Diabetes Inadequately Controlled With Oral Anti-Diabetic Drug Therapy.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in HbA1c [ Time Frame: After 24 weeks of treatment ]

Secondary Outcome Measures:

Adverse events
Weight change
Fasting blood glucose
Hypoglycaemic episodes
2-hour postprandial blood glucose
after 24 weeks of treatment.

Estimated Enrollment:	320
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Severe medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184561

Locations

China

Beijing, China

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Qian Hongyu

Novo Nordisk (China) Pharmaceuticals Co., Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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. Epub 2008 Feb 11.

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1707
Study First Received:	August 29, 2005
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00184561
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009