Status:
COMPLETED
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemi...
Eligibility Criteria
Inclusion
- FOR THE MAIN TRIAL, NN5401-3594:
- Type 1 diabetes mellitus for at least 12 months
- Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
- HbA1c 7.0-10.0% (both inclusive)
- BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
- FOR THE EXTENSION TRIAL, NN5401-3645:
- The subject must have completed the six-month treatment period in trial NN5401-3594
Exclusion
- FOR THE MAIN TRIAL, NN5401-3594:
- Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer
- FOR THE EXTENSION TRIAL, NN5401-3645:
- Anticipated significant lifestyle changes during the trial
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
548 Patients enrolled
Trial Details
Trial ID
NCT00978627
Start Date
August 1 2009
End Date
May 1 2010
Last Update
March 20 2017
Active Locations (81)
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1
Novo Nordisk Investigational Site
La Mesa, California, United States, 91942
2
Novo Nordisk Investigational Site
Lancaster, California, United States, 93534
3
Novo Nordisk Investigational Site
Mission Hills, California, United States, 91345
4
Novo Nordisk Investigational Site
North Hollywood, California, United States, 91606