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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 5, 2007
Last updated: July 4, 2012
Last verified: September 2011
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • Change of human insulin antibodies
  • Frequency of adverse events

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00569400

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

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

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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 17, 2017