Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes - Full Text View

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 aspart Insulin, isophane

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 ]

Secondary Outcome Measures:

Percentage of subjects achieving 2-hours PPPG treatment target
Percentage of subjects achieving HbA1c treatment target
HbA1c
Fasting plasma glucose
Hypoglycaemic episodes

Estimated Enrollment:	220
Study Start Date:	July 2004

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

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:	ANA-1634
Study First Received:	January 2, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00593255
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, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009