Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes

This study has been completed.

First Received: February 6, 2008 Last Updated: November 27, 2008 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00617565

Purpose

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.

Condition	Intervention	Phase
Diabetes Mellitus	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:	Comparison of Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30/70 in Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

2-hr postprandial plasma glucose (PPPG) excursion [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures:

HbA1c
Fasting plasma glucose

Estimated Enrollment:	220
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 or 2 diabetes for at least 3 months
Stabilised on current treatment with premixed human insulin for at least 4 weeks
Body mass index (BMI) between 18-40 kg/m2
HbA1c below 13.0%
Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

The receipt of any investigational drug within the last three months prior to this trial
Has a history of drug abuse or alcohol dependence within the last 5 years
Active proliferative retinopathy requiring laser or surgical intervention within the last year
Recurrent major hypoglycaemia as judged by the Investigator
Known or suspected allergy to trial product or related product

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617565

Locations

China

Beijing, China, 100034

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Plamen Kozlovski

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1536
Study First Received:	February 6, 2008
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00617565 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009