title: Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents--a randomized, prospective, crossover, open clinical trial.
abstract: BACKGROUND
  Pharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.
  
  
  METHODS
  In this 48-week, open-label, randomized, multi-center, crossover phase IV trial, insulin naïve type 2 diabetes patients with blood glucose not at target on oral hypoglycemic agents had basal insulin added to their treatment regimen. A total of 343 patients were randomized to either receive insulin glargine (n = 176; sequence A) or neutral protamine Hagedorn (NPH) insulin (n = 167; sequence B) in period 1 (weeks 1-24) and vice versa in period 2 (weeks 25-48). The primary objective was to assess patient reported outcomes using a composite Diabetes Related Quality of Life (DRQoL) score based on an unweighted Insulin Treatment Experience Questionnaire (ITEQ) score, a Problem Areas in Diabetes (PAID) questionnaire score, and the mental health score in the Short Form (SF)-12® Health Survey, analyzed by analysis of covariance (ANCOVA).
  
  
  RESULTS
  Patients (mean age 62.3 ± 9.0; 39.5 % female) had a mean diabetes duration of 9.6 ± 5.9 years, a mean baseline HbA1c of 8.15 ± 0.72 %, and a mean fasting blood glucose (FBG) level of 9.37 ± 2.19 mmol/L. A total of 229 patients were available for primary endpoint evaluation (modified intention to treat population). Combining all data from both periods for each insulin treatment, on a 0-100 scale, the mean DRQoL score was 69.6 (±9.04) with insulin glargine and 70.0 (±9.40) with NPH insulin. Neither an effect of treatment with insulin glargine vs NPH insulin (p = 0.31) nor a period effect (p = 0.96), nor a sequence effect (p = 0.76) was observed using ANCOVA.
  
  
  CONCLUSIONS
  The results show that in a patient population with sub-optimal glycemic control at baseline, and a low target achievement rate together with a low rate of hypoglycemia, differences in the patient reported outcomes evaluated in this study were negligible between insulin glargine and NPH insulin.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT00941369.
authors.affiliation: Forschungsinstitut der Diabetes Akademie Bad Mergentheim (FIDAM), Theodor-Klotzbücher-Str. 12, 97980, Bad Mergentheim, Germany. hermanns@diabetes-zentrum.de.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hermanns
authors.affiliation: Forschungsinstitut der Diabetes Akademie Bad Mergentheim (FIDAM), Theodor-Klotzbücher-Str. 12, 97980, Bad Mergentheim, Germany. kulzer@diabetes-zentrum.de.
authors.forename: Bernd
authors.initials: B
authors.lastname: Kulzer
authors.affiliation: Institute for Community Medicine, Greifswald, Germany. thomas.kohlmann@uni-greifswald.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kohlmann
authors.affiliation: Private Practice, Villingen-Schwenningen, Germany. prof.dr.jacob@web.de.
authors.forename: Stephan
authors.initials: S
authors.lastname: Jacob
authors.affiliation: Sanofi, Frankfurt, Germany. wolfgang.landgraf@sanofi.com.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Landgraf
authors.affiliation: Sanofi, Frankfurt, Germany. karlheinz.theobald@sanofi.com.
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Theobald
authors.affiliation: Forschungsinstitut der Diabetes Akademie Bad Mergentheim (FIDAM), Theodor-Klotzbücher-Str. 12, 97980, Bad Mergentheim, Germany. haak@diabetes-zentrum.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Haak
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000523:psychology*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage; D049528:Insulin, Long-Acting / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010549:Personal Satisfaction; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting