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
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 1 - 17 |
| Updated: | 9/12/2018 |
| Start Date: | October 17, 2013 |
| End Date: | November 7, 2014 |
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 for the remaining meals in children and adolescents with type 1 diabetes
mellitus.
to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus
insulin aspart for the remaining meals in children and adolescents with type 1 diabetes
mellitus.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
23
sites
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