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

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 Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Drug: soluble human insulin Drug: insulin aspart Drug: insulin NPH	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 2

Drug Information available for: Insulin Insulin human Insulin, isophane Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


China, Beijing

Beijing, Beijing, China, 100853

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Ma Zhaoyu, BS	Novo Nordisk A/S
Study Director:	Cheng Yuwei, BS	Novo Nordisk A/S

More Information

Additional Information:

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


Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00593255 History of Changes
Other Study ID Numbers:	ANA-1634
Study First Received:	January 2, 2008
Last Updated:	May 24, 2012
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Insulin, Globin Zinc	Insulin degludec, insulin aspart drug combination Isophane insulin, beef Insulin Insulin Aspart Insulin, Long-Acting Isophane Insulin, Human Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016