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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.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00569400
First received: December 5, 2007
Last updated: February 23, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date: May 1, 2003
Study Completion Date: January 19, 2004
Primary Completion Date: January 19, 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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, New South Wales
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
Australia, South Australia
Novo Nordisk Investigational Site
Keswick, South Australia, Australia, 5035
Australia
Novo Nordisk Investigational Site
Dunedin, Australia, NZ
Novo Nordisk Investigational Site
Hamilton, Australia, NZ
Novo Nordisk Investigational Site
Kippa Ring, Australia, 4021
Novo Nordisk Investigational Site
Miranda, Australia, 2228
Novo Nordisk Investigational Site
Stones Corner, Australia, 4120
Hong Kong
Novo Nordisk Investigational Site
Shatin, New Territories, Hong Kong
Malaysia
Novo Nordisk Investigational Site
Cheras, Malaysia, 56000
Novo Nordisk Investigational Site
Georgetown, Penang, Malaysia, 10450
Novo Nordisk Investigational Site
Kota Bharu, Kelantan, Malaysia, 16150
Philippines
Novo Nordisk Investigational Site
Cebu City, Philippines, 6000
Novo Nordisk Investigational Site
Iloilo, Philippines
Novo Nordisk Investigational Site
Makati City, Philippines, 1200
Novo Nordisk Investigational Site
Marikina City, Philippines, 1800
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: 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: February 23, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017