title: Improved treatment satisfaction in patients with type 1 diabetes treated with insulin glargine 100U/mL versus neutral protamine Hagedorn insulin: An exploration of key predictors from two randomized controlled trials.
abstract: OBJECTIVE
  Investigate contributors to treatment satisfaction in type 1 diabetes (T1D).
  
  
  METHODS
  Post-hoc analysis using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) in 771 T1D patients from two 28-week trials comparing once-daily insulin glargine 100U/mL (Gla-100) with once- or twice-daily NPH neutral protamine Hagedorn (NPH) insulin.
  
  
  RESULTS
  Gla-100 was associated with a significant improvement in treatment satisfaction versus NPH (overall population adjusted mean [standard error] DTSQs change from baseline: +1.13 [0.30] versus -0.04 [0.31]; p=0.006). In the overall population, treatment satisfaction improvement with all insulin regimens was related to less frequent severe hypoglycemia (coefficient-0.077; p=0.040) and HbA1c reduction (-0.066; p=0.082). By treatment regimen, relationships between treatment satisfaction and these outcomes approached or attained statistical significance for NPH insulin, but not Gla-100. In the overall population, predictors of treatment satisfaction improvement included: Gla-100 treatment (estimate 1.17, p=0.006), lower baseline DTSQs (-0.57, p<0.001), study (-1.01, p=0.019), lower severe hypoglycemia rate (0.17, p=0.012), and higher baseline HbA1c (0.44, p=0.014). By treatment regimen, these predictors remained significant for NPH insulin.
  
  
  CONCLUSIONS
  Gla-100 resulted in a significant improvement in treatment satisfaction versus NPH insulin, independent of baseline disease characteristics and clinical outcomes.
authors.affiliation: University of California San Diego, San Diego, CA, USA; Behavioral Diabetes Institute, San Diego, CA, USA. Electronic address: whp@behavioraldiabetes.org.
authors.forename: William
authors.initials: W
authors.lastname: Polonsky
authors.affiliation: Sanofi US, Inc., Bridgewater, NJ, USA.
authors.forename: Louise
authors.initials: L
authors.lastname: Traylor
authors.affiliation: Analysta Inc., Somerset, NJ, USA.
authors.forename: Ling
authors.initials: L
authors.lastname: Gao
authors.affiliation: Sanofi US, Inc., Bridgewater, NJ, USA.
authors.forename: Wenhui
authors.initials: W
authors.lastname: Wei
authors.affiliation: Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Ameer
authors.affiliation: Bayer Diabetes Care, Whippany, NJ, USA.
authors.forename: Andreas
authors.initials: A
authors.lastname: Stuhr
authors.affiliation: Sanofi US, Inc., Bridgewater, NJ, USA.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Vlajnic
mesh_terms: D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D004351:Drug Resistance; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000503:physiopathology / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced / Q000503:physiopathology / Q000517:prevention & control*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069036:Insulin Glargine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D007336:Insulin, Isophane; C517652:hemoglobin A1c protein, human
keywords: Diabetes Treatment Satisfaction Questionnaire; Insulin glargine 100U/mL; Insulin therapy; NPH insulin; Patient-reported outcomes; Type 1 diabetes