title: The INITIATOR study: pilot data on real-world clinical and economic outcomes in US patients with type 2 diabetes initiating injectable therapy.
abstract: BACKGROUND
  Type 2 diabetes mellitus (T2DM) progression often results in treatment intensification with injectable therapy to maintain glycemic control. Using pilot data from the Initiation of New Injectable Treatment Introduced after Anti-diabetic Therapy with Oral-only Regimens study, real-world treatment patterns among T2DM patients initiating injectable therapy with insulin glargine or liraglutide were assessed.
  
  
  METHODS
  This was a retrospective analysis of claims from the OptumInsight™ (OI; January 1, 2010 to July 30, 2010) and HealthCore(®) (HC; January 1, 2010 to June 1, 2010) health insurance databases. Baseline characteristics, health care resource utilization, and costs were compared between adults with T2DM initiating injectable therapy with insulin glargine pen versus liraglutide. Follow-up outcomes, including glycated hemoglobin A1c (A1C), hypoglycemia, health care utilization, and costs, were assessed.
  
  
  RESULTS
  At baseline, almost one in three liraglutide patients (OI, n = 363; HC, n = 521) had A1C <7.0%, while insulin glargine patients (OI, n = 498; HC, n = 1,188) had poorer health status, higher A1C (insulin glargine: 9.8% and 9.1% versus liraglutide: 7.9% and 7.7%, OI and HC, respectively, both P < 0.001), and were less likely to be obese (insulin glargine: 10.8% and 9.2% versus liraglutide: 17.4% and 18.8%, OI and HC, respectively, both P < 0.01). The percentage of patients experiencing a hypoglycemic event was numerically higher for insulin pen use for both cohorts (OI 4.4% versus 3.0%; HC 6.2% versus 2.3%). During follow-up, in the insulin glargine cohort, annualized diabetes-related costs remained unchanged ($8,344 versus $7,749 OI, and $7,094 versus $7,731 HC), despite a significant increase in pharmacy costs, due to non-significant decreases in medical costs, while the liraglutide cohort had a significant increase in annualized diabetes-related costs ($4,510 versus $7,731 OI, and $4,136 versus $7,111 HC; both P < 0.001) due to a non-significant increase in medical costs coupled with a significant increase in pharmacy costs.
  
  
  CONCLUSIONS
  These descriptive data identified differences in demographic and baseline clinical characteristics among patients initiating injectable therapies. The different health care utilization and cost patterns warrant further cost-effectiveness analysis.
authors.affiliation: OptumInsight, Eden Prairie, MN, USA, sarah.thayer@optum.com.
authors.forename: Sarah
authors.initials: S
authors.lastname: Thayer
authors.forename: Wenhui
authors.initials: W
authors.lastname: Wei
authors.forename: Erin
authors.initials: E
authors.lastname: Buysman
authors.forename: Lee
authors.initials: L
authors.lastname: Brekke
authors.forename: William
authors.initials: W
authors.lastname: Crown
authors.forename: Michael
authors.initials: M
authors.lastname: Grabner
authors.forename: Swetha
authors.initials: S
authors.lastname: Raparla
authors.forename: Ralph
authors.initials: R
authors.lastname: Quimbo
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Cziraky
authors.forename: Wenli
authors.initials: W
authors.lastname: Hu
authors.forename: Robert
authors.initials: R
authors.lastname: Cuddihy
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects*; D015331:Cohort Studies; D003362:Cost-Benefit Analysis; D016208:Databases, Factual; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy*; D004209:Disposable Equipment / Q000191:economics; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000191:economics*; D007279:Injections, Subcutaneous; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000191:economics; D000069450:Liraglutide; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013594:Syringes / Q000191:economics; D016896:Treatment Outcome; D014481:United States
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; D000069036:Insulin Glargine; D000069450:Liraglutide; D052216:Glucagon-Like Peptide 1