Table 1

Clinical parameters used in the (A) main cost analyses and (B) sensitivity analyses

Clinical inputsIDetRatio (degludec/IDet)Degludec (estimated)
(A)
Basal insulin dose (units/day)
 All patients
 (n=273)
20.850.7014.60
Rate of hyperglycemia with ketosis (number of events per PYE)
 Ketones >1.5 mmol/L (27.0 mg/dL)1.100.410.45
Clinical inputsIDetRatio (degludec/IDet)Degludec (estimated)
(B)
Basal insulin dose (units/day)
 1–5 years of age
 (n=63)
9.850.706.90
 6–11 years of age
 (n=112)
17.710.7012.40
 12–17 years of age
 (n=98)
31.680.7022.18
Rate of hyperglycemia with ketosis (number of events per PYE)
 Ketones >0.6 mmol/L (10.8 mg/dL)6.140.442.70
 Ketones >3.0 mmol/L (54 mg/dL)0.230.280.06
  • N=number of patients completing main trial and extension period (total 52 weeks) from the BEGIN YOUNG 1 study.14 All treatment differences associated with the dose ratios and rate ratios were significant. The basal insulin dose ratio, number of hyperglycemic events with ketones >1.5 mmol/L (27.0 mg/dL) per PYE with IDet and the corresponding rate ratio with degludec vs IDet were taken from BEGIN YOUNG 1.14 The numbers of hyperglycemic events with ketones >0.6 mmol/L (10.8 mg/dL) and >3.0 mmol/L (54 mg/dL) per PYE, and the corresponding rate ratios with degludec vs IDet were retrieved from a secondary analysis of two phase IIIb trials investigating degludec and degludec with insulin aspart vs IDet.16 The number of hyperglycemic events with ketosis per PYE for degludec were estimated as the number per PYE for IDet multiplied by the corresponding rate ratios. The dose (units/day) of IDet was calculated as 0.55 units/kg (dose of IDet at the end of the BEGIN YOUNG 1 trial)14 multiplied by the average weight (37.9 kg) of all patients (Table 1A). The dose (units/day) of degludec was estimated by multiplying the daily dose ratio of 0.7 from BEGIN YOUNG 114 by the calculated daily dose of IDet.

  • IDet, insulin detemir; PYE, patient-year of exposure.