Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

This study has been completed.

First Received: January 2, 2008 Last Updated: April 30, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00593255

Purpose

This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: soluble human insulin Drug: insulin aspart Drug: insulin NPH	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin, isophane 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 Insulin Aspart Plus NPH Insulin to Soluble Human Insulin + NPH Insulin in Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

2-hours postprandial plasma glucose (PPPG) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects achieving 2-hours PPPG treatment target [ Designated as safety issue: No ]
Percentage of subjects achieving HbA1c treatment target [ Designated as safety issue: No ]
HbA1c [ Designated as safety issue: No ]
Fasting plasma glucose [ Designated as safety issue: No ]
Hypoglycaemic episodes [ Designated as safety issue: No ]

Enrollment:	220
Study Start Date:	July 2004
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 or 2 diabetes for at least 4 weeks
Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
HbA1c: 7.5-13.5%
Body Mass Index (BMI): 18-35 kg/m2

Exclusion Criteria:

Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
History of drug abuse or alcohol dependence

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593255

Locations

China

Beijing, China, 100853

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Ma Zhaoyu, BS	Novo Nordisk
Study Director:	Cheng Yuwei, BS	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:	ANA-1634
Study First Received:	January 2, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00593255 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

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

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin, Isophane
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