Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Subjects with type 1 diabetes
- Duration of diabetes for at least 12 months
- Treatment with insulin aspart for at least 3 months before trial start
- Body Mass Index (BMI) below 35.0 kg/m2
- HbA1c below 12.0%
Exclusion Criteria:
- Total insulin dosage more than 1.4 IU/kg/day
- Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
- Known hypoglycaemia unawareness as judged by the investigator
- Known hypersensitivity or allergy
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
- 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
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Insulin aspart antibodies
Secondary Outcome Measures
Occurrence of adverse events
Incidence of hypoglycaemic episodes
HbA1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00604656
Brief Title
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
Official Title
A Six Months, Multi-centre, Open, Randomised, Parallel Safety and Efficacy Comparison of NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process in Subjects With Type 1 Diabetes on a Basal/Bolus Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 5, 2003 (Actual)
Primary Completion Date
January 29, 2004 (Actual)
Study Completion Date
January 29, 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 Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 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)
insulin aspart
Primary Outcome Measure Information:
Title
Insulin aspart antibodies
Time Frame
After 6 months treatment
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Title
Incidence of hypoglycaemic episodes
Title
HbA1c
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with type 1 diabetes
Duration of diabetes for at least 12 months
Treatment with insulin aspart for at least 3 months before trial start
Body Mass Index (BMI) below 35.0 kg/m2
HbA1c below 12.0%
Exclusion Criteria:
Total insulin dosage more than 1.4 IU/kg/day
Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
Known hypoglycaemia unawareness as judged by the investigator
Known hypersensitivity or allergy
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
Hradec Králové
ZIP/Postal Code
500 36
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Praha 5
ZIP/Postal Code
15018
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Neuenahr-Ahrweiler
ZIP/Postal Code
53474
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Diez
ZIP/Postal Code
65582
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Frankfurt
ZIP/Postal Code
60325
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Marktheidenfeld
ZIP/Postal Code
97828
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Marl
ZIP/Postal Code
45770
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oberursel
ZIP/Postal Code
61440
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saarbrücken
ZIP/Postal Code
66121
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Simmern
ZIP/Postal Code
55469
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Speyer
ZIP/Postal Code
67346
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Würzburg
ZIP/Postal Code
97072
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Chiavari
ZIP/Postal Code
16043
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Citta' Di Castello
ZIP/Postal Code
06012
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Orvieto
ZIP/Postal Code
05018
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Perugia
ZIP/Postal Code
06126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Mazowieckie
ZIP/Postal Code
09-400
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Radom
ZIP/Postal Code
26-600
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warsaw
ZIP/Postal Code
03-242
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Wroclaw
ZIP/Postal Code
50-306
Country
Poland
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes
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