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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569400
First received: December 5, 2007
Last updated: July 4, 2012
Last verified: September 2011
  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
Diabetes Mellitus, Type 1
Drug: human insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus

Resource links provided by NLM:


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

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 ]

Enrollment: 241
Study Start Date: May 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
  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
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: NCT00569400

Locations
Australia
Stones Corner, Australia, 4120
Hong Kong
Hong Kong, Hong Kong
Malaysia
Cheras, Malaysia, 56000
New Zealand
Hamilton, New Zealand, NZ
Philippines
Marikina City, Philippines, 1800
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Karsten Lyby, MSc Odont Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00569400     History of Changes
Other Study ID Numbers: NN729-1541
Study First Received: December 5, 2007
Last Updated: July 4, 2012
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014