Status:
COMPLETED
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart fo...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes mellitus - HbA1c below or equal to 11.0%
Exclusion
- Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
Key Trial Info
Start Date :
October 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2014
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT01835431
Start Date
October 17 2013
End Date
November 7 2014
Last Update
June 11 2019
Active Locations (73)
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1
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85053
2
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85724
3
Novo Nordisk Investigational Site
Sacramento, California, United States, 95816
4
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045