title: Replacing Insulin Glargine with Neutral Protamine Hagedorn (NPH) Insulin in a Subpopulation of Study Subjects in the Action to Control Cardiovascular Risk in Diabetes (ACCORD): Effects on Blood Glucose Levels, Hypoglycemia and Patient Satisfaction.
abstract: OBJECTIVE
  To ensure patient safety when replacing insulin glargine (IG) with neutral protamine Hagedorn (NPH) insulin and to determine differences in blood glucose control, frequency of hypoglycemia, insulin dosing, health resource utilization and quality of life between users of IG and NPH insulin.
  
  
  METHODS
  A single-site, open-label, randomized, 6-month comparative study of 66 patients from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Randomization was 1:1 to receive IG or NPH insulin. Data regarding blood glucose control, insulin dosage adjustment and recording of hypoglycemia episodes were obtained through telephone calls; office visits were conducted to measure weight, glycated hemoglobin, fasting plasma glucose and blood glucose profile. The Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used to measure patients' satisfaction with their diabetes treatment.
  
  
  RESULTS
  Rates of symptomatic hypoglycemia did not differ significantly between groups: 37.5±2.2 for the IG group and 31.1±2.1 for the NPH group. However, patients treated with NPH insulin had higher frequencies of severe hypoglycemia (6.1±0.9) compared with 2.7±0.6 for the IG group. A significant difference in changes in glycated hemoglobin (A1C) was observed between the groups: the mean ± standard error A1C decreases from baseline were -0.34%±0.11 for the IG group, vs -0.01%±0.10 for the NPH insulin group. The data obtained from the DTSQ showed greater treatment satisfaction in the IG group compared with the NPH insulin group.
  
  
  CONCLUSIONS
  Switching from IG to NPH insulin resulted in more than double the rate of severe hypoglycemias and led to decreased metabolic control. Greater treatment satisfaction was observed with IG, compared with NPH insulin, as measured by change from baseline in the DTSQ scores.
authors.affiliation: University of Manitoba, Department of Medicine, Section of Endocrinology, Winnipeg Regional Health Authority, Health Sciences Centre, Winnipeg Diabetes Research Group, Winnipeg, Manitoba, Canada. Electronic address: ldberard@gmail.com.
authors.forename: Lori
authors.initials: L
authors.lastname: Berard
authors.affiliation: University of Manitoba, Department of Medicine, Section of Endocrinology, Winnipeg Regional Health Authority, Health Sciences Centre, Winnipeg Diabetes Research Group, Winnipeg, Manitoba, Canada.
authors.forename: Brett
authors.initials: B
authors.lastname: Cameron
authors.affiliation: University of Manitoba, Department of Medicine, Section of Endocrinology, Winnipeg Regional Health Authority, Health Sciences Centre, Winnipeg Diabetes Research Group, Winnipeg, Manitoba, Canada.
authors.forename: Vincent
authors.initials: V
authors.lastname: Woo
authors.affiliation: Sanofi Canada, Laval, Québec, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Stewart
mesh_terms: D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000097:blood / Q000517:prevention & control*; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D057915:Drug Substitution / Q000009:adverse effects; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000139:chemically induced*; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use; D000069036:Insulin Glargine / Q000494:pharmacology / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D017060:Patient Satisfaction; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D000069036:Insulin Glargine; D007336:Insulin, Isophane
keywords: A1C; A1c; NPH insulin; blood glucose; glargine insulin; glycémie; hypoglycemia; hypoglycémie; insuline NPH; insuline glargine; patient satisfaction; satisfaction des patients