Back to resultsComparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
human insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Change of human insulin antibodies
Secondary Outcome Measures
Change of human insulin antibodies
Frequency of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00569400
Brief Title
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
Official Title
Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2003 (Actual)
Primary Completion Date
January 19, 2004 (Actual)
Study Completion Date
January 19, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
human insulin
Primary Outcome Measure Information:
Title
Change of human insulin antibodies
Time Frame
after 26 weeks of treatment
Secondary Outcome Measure Information:
Title
Change of human insulin antibodies
Title
Frequency of adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Dunedin
ZIP/Postal Code
NZ
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
ZIP/Postal Code
NZ
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Kippa Ring
ZIP/Postal Code
4021
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Miranda
ZIP/Postal Code
2228
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Stones Corner
ZIP/Postal Code
4120
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Novo Nordisk Investigational Site
City
Cheras
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Georgetown, Penang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu, Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Iloilo
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Novo Nordisk Investigational Site
City
Marikina City
ZIP/Postal Code
1800
Country
Philippines
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
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