Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00476437

Purpose

This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.

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

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:	Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of hypoglycaemic episodes [ Time Frame: During 16 weeks of treatment ]

Estimated Enrollment:	75
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus
Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
HbA1C: less than 11.0%
BMI: less than 30.0 kg/m2

Exclusion Criteria:

Total daily insulin dose: 100 IU/U and more
Treatment with oral hypoglycaemic agents within the last 4 weeks.
Treatment with insulin sensitizer within the last 12 weeks
A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476437

Locations

Japan

Tokyo, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Muneharu Kagawa

Novo Nordisk Pharma Ltd.

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1864, JAPIC: JapicCTI-070408
Study First Received:	May 21, 2007
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00476437
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 16, 2009