3561 Insulin degludec in children and adolescents with type 1 diabetes

• Research type

  Research Study

• Full title

  A 26-week, Multinational, Multi-centre, Open-Labelled, Randomised, Parallel, Efficacy and Safety Comparison of Insulin Degludec and Insulin Detemir in children and adolescents 1 to less than 18 years with type 1 Diabetes Mellitus on a basal-bolus regimen with insulin aspart as bolus insulin.

• IRAS ID

  90594

• Contact name

  Timothy Barrett

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2011-003148-39

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of the study is to compare the blood sugar lowering effect and safety of a new long-acting insulin analogue (insulin degludec) with that of a marketed insulin analogue (insulin detemir or Levemir©) in children and adolescents between the ages of 1 and 17 (age at randomisation). All patients will receive insulin aspart (NovoRapid©) as mealtime (bolus) insulin. Long-acting insulins will be injected either once a day (insulin degludec or once to twice a day (Levemir©). Patients will be asked to come to the clinic for a total of 11 visits over a 6 month period. They will also be contacted by phone by members of the study team at least 18 times. In addition to providing information about their general health (date of birth, gender etc), patients will be fully assessed by the study team at each site and will have blood samples taken. At selected sites (exact sites to be confirmed) patients will also be invited to take part in a continuous glucose monitoring (CGM) sub-study. This will involve wearing a CGM device (sensor to be inserted under the skin by the study team) for up to 72 hours before 2 of the clinic visits. Participation in the sub-study is entirely voluntary and patients will be permitted to take part in the main study even if they refuse to participate in the sub-study. There will also be a six month extension to the study that study subjects may participate in if they wish to do so.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0513

• Date of REC Opinion

  5 Jan 2012

• REC opinion

  Further Information Favourable Opinion