title: [Effectiveness and safety of initiation of once-daily insulin detemir in Chinese patients with type 2 diabetes previously treated with different quantities of oral anti-diabetic drugs: subgroup analysis of the Chinese SOLVE™ Study].
abstract: OBJECTIVE
  To evaluate the effectiveness and safety on once-daily (OD) insulin detemir (IDet) in Chinese patients with type 2 diabetes mellitus (T2DM) who were treated with different types or combinations of oral anti-diabetic drugs (OADs).
  
  
  METHODS
  The SOLVE™ study was a 24-week observational study on the initiation of IDet OD in T2DM patients with uncontrolled hyperglycemia on diet, exercise, and one or more OADs. Subjects were grouped based on the numbers of OADs taken before (>2-OAD, 2-OAD, and 1-OAD groups). Efficacy and safety endpoints were evaluated and compared in different groups.
  
  
  RESULTS
  This study includes 3 272 patients, among them 464 (14.2%) were treated with more than 2 OADs, 1511 (46.2%) with 2 OADs, and 1 218 (37.2%) with 1 OAD before the study. The mean glycosylated hemoglobin A1c (HbA1c) was 8.4%, 8.3%, 8.4% at baseline, and 7.3%, 7.2%, 7.1% at the end of 24-week in each 3 groups (all P<0.001 vs. baseline values). The HbA1c reductions were not statistically significant different among groups. Body weight tended to decrease in patients from all groups, however, only that in the 2-OAD group reached statistically significance. No major hypoglycaemia events were reported. However, the overall minor hypoglycaemia rate in the 2-OAD group was higher at the end of the study than that at baseline (P<0.05). No differences in the rate of nocturnal minor hypoglycaemia were observed in all groups after IDet treatment.
  
  
  CONCLUSIONS
  Initiation of IDet OD was effective and well-tolerated in Chinese patients with T2DM whose glycemia was poorly controlled on OADs irrespective of the number of OADs taken before. (registration number NCT00825643).
authors.affiliation: Department of Endocrinology, Chinese PLA General Hospital, Beijing 100853, China; Email: panchy301@126.com.
authors.forename: Changyu
authors.initials: C
authors.lastname: Pan
authors.forename: Linong
authors.initials: L
authors.lastname: Ji
authors.forename: Juming
authors.initials: J
authors.lastname: Lu
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.forename: Zhiguang
authors.initials: Z
authors.lastname: Zhou
mesh_terms: D001786:Blood Glucose / Q000187:drug effects*; D002681:China / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy; D007003:Hypoglycemia; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069057:Insulin Detemir; D049528:Insulin, Long-Acting