Status:
COMPLETED
A Trial Investigating the Efficacy and Safety of Insulin Degludec 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 Africa, Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents...
Eligibility Criteria
Inclusion
- Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
- Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
- Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
- HbA1c (glycosylated haemoglobin) maximum 11%
Exclusion
- Known or suspected hypersensitivity to trial product(s) or related products
- Previous participation in this trial. Participation is defined as randomisation
- Girls who are pregnant, breastfeeding or intend to become pregnant
- Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
- Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
- More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
- Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
- The receipt of any investigational drug within 1 month prior to Visit 1
Key Trial Info
Start Date :
January 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2013
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01513473
Start Date
January 16 2012
End Date
July 30 2013
Last Update
June 13 2019
Active Locations (81)
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1
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72202
2
Novo Nordisk Investigational Site
Orange, California, United States, 92868
3
Novo Nordisk Investigational Site
San Diego, California, United States, 92123
4
Novo Nordisk Investigational Site
Aurora, Colorado, United States, 80045