Diabetes Mellitus, Type 1 MedDRA version: 14.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: IDeg Penfill
Pharmaceutical Form: Solution for injection
INN or Proposed INN: insulin degludec
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equ
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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. 2) Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines). 3) Age: 1 to less than 18 years of age at randomisation 4) Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1. No OADs are allowed. 5) HbA1c = 11% 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
Exclusion criteria: 1) Known or suspected hypersensitivity to trial product(s) or related products 2) Previous participation in this trial. Participation is defined as randomisation 3) Girls who are pregnant, breastfeeding or intend to become pregnant 4) Girls, who have had menarche and are not using adequate contraceptive measures according to local requirements 5) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator 6) More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 7) Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator’s opinion could interfere with the trial 8) The receipt of any investigational drug within 1 month prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HBA1c after 26 weeks of treatment. This is done by comparing the difference in change in HbA1c between insulin degludec + insulin aspart and insulin detemir + insulin aspart to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.;Secondary Objective: 1. To compare the efficacy and safety between the two treatment arms after 26 weeks of treatment in terms of: - Other parameters of glycaemic control - Safety 2. To investigate the pharmacokinetics of insulin degludec and insulin detemir in different age groups using a sparse sampling approach and population PK modelling;Primary end point(s): Change from baseline in HbA1c (%) after 26 weeks of treatment;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in fasting blood glucose (FPG) after 26 weeks of treatment (analysed by central laboratory) 2. Number of treatment emergent adverse events (TEAEs) 3. Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) = 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 – 07:00] and over the entire day (24 hours) after 26 weeks of treatment 4. Number of self-measured hyperglycaemia (episodes of PG > 11.1 mmol/L (200 mg/dL)) after 26 weeks of treatment 5. Number of episodes with self monitored blood ketones >1.5 mmol (capillary blood ketone measurement to be performed if self-measured plasma glucose (SMPG) exceeds 14.0 mmol/l (250 mg/dL)) after 26 weeks of treatment 6. Steady-state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment 2. After 26 weeks of treatment 3. After 26 weeks of treatment 4. After 26 weeks of treatment 5. After 26 weeks of treatment 6. After 26 weeks of treatment | — |
Countries
Bulgaria, Finland, France, Germany, Italy, Japan, Macedonia, the former Yugoslav Republic of, Netherlands, Russian Federation, South Africa, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed