title: Insulin degludec early clinical experience: does the promise from the clinical trials translate into clinical practice--a case-based evaluation.
abstract: BACKGROUND
  Clinical experience of patients is an additional source of information that can inform prescribing decisions for new therapies in practice. In diabetes, for example, patients with recurrent hypoglycemia may be excluded from trials conducted for regulatory purposes. Using insulin degludec (IDeg), a new basal insulin with an ultra-long duration of action as an example, an interim analysis is presented describing whether the decision to prescribe IDeg to patients experiencing treatment-limiting problems on their existing insulin regimes represented good clinical and economic value.
  
  
  METHODS
  Records from the first 51 consecutive patients with diabetes (35 type 1 [T1D] and 16 type 2 [T2D]) switching to insulin degludec from either insulin glargine (IGlar) or insulin detemir (IDet), mostly due to problems with hypoglycemia (39/51, 76.5%), were reviewed at up to 37 weeks. Patients indicated frequency of hypoglycemia and completed a disease-specific questionnaire reporting six measures of confidence and treatment satisfaction. For the largest group of exposed patents, the T1D module of the IMS Core Diabetes Model (CDM) was used to evaluate the cost-effectiveness of the treatment decision.
  
  
  RESULTS
  HbA1c decreased by 0.5 ± 0.3% points and 0.7 ± 0.3% points for T1D and T2D, respectively. Hypoglycemic events decreased by >90%. Combined mean scores were ≥ 3.7 (1 = much worse, 3 = no change, 5 = much improved) for all six satisfaction and confidence items. In T1D, the treatment decision was highly cost-effective in the CDM lifetime analysis. Even when excluding benefits beyond hypoglycemia reduction, predicted cost per quality-adjusted life-year for IDeg vs IGlar/IDet was £10,754.
  
  
  CONCLUSIONS
  These data illustrate the complementary nature of clinical trial and practice data when evaluating the value of therapeutic innovations in diabetes care. There were reductions in patient-reported hypoglycemia, reduced HbA1c, and improved treatment satisfaction in relation to the decision to prescribe IDeg. Initial health economic evaluation suggested that the decision to prescribe IDeg in this phenotypic group of T1D patients represented good value for money.
authors.affiliation: Llandough Hospital, Diabetes Resource Centre , Cardiff , UK.
authors.forename: Marc
authors.initials: M
authors.lastname: Evans
authors.forename: Phil
authors.initials: P
authors.lastname: McEwan
authors.forename: Volker
authors.initials: V
authors.lastname: Foos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose; D003362:Cost-Benefit Analysis; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000191:economics* / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000191:economics* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D019057:Quality-Adjusted Life Years; D012189:Retrospective Studies
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; C571886:insulin degludec
keywords: Diabetes treatment; Health economics; Hypoglycemia; Insulin; Insulin degludec