EUCTR2012-003566-41-BE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 346
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) 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.
- •2\) Subjects diagnosed with type 1 diabetes mellitus
- •3\) Age: 1 to \<18 years of age at randomisation
- •4\) HbA1c \= 11\.0%
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 346
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator
- •2\) More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening)
- •3\) Any chronic disorder or significant concomitant disease, which in the investigator’s opinion might jeopardise the subject’s safety or compliance with the protocol
Outcomes
Primary Outcomes
Not specified
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