Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes

This study has been completed.

First Received: December 5, 2007 Last Updated: March 26, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00569400

Purpose

This trial is conducted in Asia and Oceania.

The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: human insulin	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

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 Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change of human insulin antibodies [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of human insulin antibodies [ Designated as safety issue: No ]
Frequency of adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	May 2003

Eligibility

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

Criteria

Inclusion Criteria:

Duration of diabetes for at least 12 months
Basal/bolus treatment with human insulin for at least 2 months preceding trial start
Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
HbA1c lesser than or equal to 12.0%

Exclusion Criteria:

Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
Any condition that the investigator and/or sponsor feel would interfere with trial participation
Known or suspected allergy against trial product or related products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569400

Locations

Australia, Queensland

Stones Corner, Queensland, Australia, 4120
Hong Kong

Hong Kong, Hong Kong
Malaysia, Kuala Lumpur

Cheras, Kuala Lumpur, Malaysia, 56000
New Zealand

Hamilton, New Zealand, NZ
Philippines, Metro Manila

Marikina City, Metro Manila, Philippines, 1800

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Karsten Lyby, MSc Odont

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:	NN729-1541
Study First Received:	December 5, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00569400 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Food Safety Authority; Malaysia: Ministry of Health; Philippines: Bureau of Food and Drugs; Hong Kong: Department of Health

Study placed in the following topic categories:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Diabetes Mellitus Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009