title: Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial.
abstract: BACKGROUND
  The aim of the present 24-week multicentre randomized non-inferiority trial was to compare the efficacy and safety of two insulin intensification strategies in uncontrolled type 2 diabetes despite optimized basal insulin therapy.
  
  
  METHODS
  Patients with fasting plasma glucose (FPG) <130 mg/dL and HbA1c 7.0%-10.0% while on insulin glargine were randomized to a basal-prandial group (stepwise addition of insulin glulisine) or a premixed insulin group (insulin aspart/insulin aspart protamine 30/70 starting with 6 IU twice daily). The primary endpoint was the change in HbA1c after 24 weeks (non-inferiority margin 0.4%).
  
  
  RESULTS
  At Week 24, the adjusted mean change from baseline HbA1c was -0.94 ± 0.09% and -1.04 ± 0.09% in basal-prandial and premixed insulin groups, respectively, with a mean difference of -0.09% (95% confidence interval [CI] -0.35, 0.16). A lower rate of hypoglycemia with a similar reduction in HbA1c was observed during stabilization of the total daily insulin dose in the premixed insulin group (Weeks 0-12). After stabilization of the total daily insulin dose, the rate of hypoglycemia and the total daily insulin dose were similar in the two groups.
  
  
  CONCLUSIONS
  The efficacy and safety of the two intensifying regimens were similar after stabilization of the total daily insulin dose when oral agents were maintained. Starting with a lower total daily insulin dose with a gradual change in the treatment regimen was helpful in reducing the rate of hypoglycemia during initial stabilization of the total daily insulin dose.
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Sang-Man
authors.initials: SM
authors.lastname: Jin
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Jae Hyeon
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Diabetes Center, Eulji General Hospital, Eulji University School of Medicine, Seoul, South Korea.
authors.forename: Kyung Wan
authors.initials: KW
authors.lastname: Min
authors.affiliation: Catholic University of Daegu.
authors.forename: Ji Hyun
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Kyung Hee University School of Medicine, Seoul, South Korea.
authors.forename: Kue Jeong
authors.initials: KJ
authors.lastname: Ahn
authors.affiliation: College of Medicine, Paik Institute for Clinical Research, Inje University, Busan, South Korea.
authors.forename: Jeong Hyun
authors.initials: JH
authors.lastname: Park
authors.affiliation: Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
authors.forename: Hak Chul
authors.initials: HC
authors.lastname: Jang
authors.affiliation: CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea.
authors.forename: Seok Won
authors.initials: SW
authors.lastname: Park
authors.affiliation: Ajou University School of Medicine, Suwon, South Korea.
authors.forename: Kwan Woo
authors.initials: KW
authors.lastname: Lee
authors.affiliation: Yeungnam University College of Medicine, Daegu, South Korea.
authors.forename: Kyu Chang
authors.initials: KC
authors.lastname: Won
authors.affiliation: Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
authors.forename: Young-Il
authors.initials: YI
authors.lastname: Kim
authors.affiliation: Wonju College of Medicine, Yonsei University, Wonju, South Korea.
authors.forename: Choon Hee
authors.initials: CH
authors.lastname: Chung
authors.affiliation: Chonbuk National University Medical School, Jeonju, South Korea.
authors.forename: Tae Sun
authors.initials: TS
authors.lastname: Park
authors.affiliation: Departments of Internal Medicine, Sanofi-Aventis Korea Co. Ltd, Seoul, South Korea.
authors.forename: Jee-Hyun
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Moon-Kyu
authors.initials: MK
authors.lastname: Lee
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D061267:Insulin Aspart / Q000008:administration & dosage; D000069036:Insulin Glargine / Q000008:administration & dosage; D061268:Insulin Lispro / Q000008:administration & dosage; D008297:Male; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D000069036:Insulin Glargine; D061268:Insulin Lispro; C479079:insulin glulisine
keywords: basal-prandial; glargine; glulisine; premixed insulin; 基础-餐时; 甘精胰岛素; 赖谷胰岛素; 预混胰岛素