title: Effects of a combination of oral anti-diabetes drugs with basal insulin therapy on β-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes.
abstract: BACKGROUND
  Oral anti-diabetes drugs plus basal insulin (OAD + insulin) therapy in patients with newly diagnosed type 2 diabetes might improve β-cell function and result in extended glycaemic remission. This randomised trial compared the effect on β-cell function and diabetes remission rate between oral drug alone or with addition of basal insulin.
  
  
  METHODS
  One hundred and twenty-nine patients, aged 35-50 years, were enrolled between June 2005 and June 2009. For initial correction of hyperglycaemia, patients with fasting plasma glucose ≥9.0 mmol/L and HbA(1c) ≥ 9.0%, were randomly assigned to therapy with oral drugs + insulin or oral drugs alone. Treatment was stopped after normoglycaemia was maintained for 3 months. Patients were then followed-up with diet and physical exercise. Blood glucose, HbA(1c) and insulin were measured prior to treatment and at 1-year follow-up.
  
  
  RESULTS
  More patients achieved target glycaemic control in the oral drugs + insulin group [98.3% (58 of 59)] in less time [(10.4 ± 2.5) days] than those in the oral drug group [95.7% (67 of 70) and (12.4 ± 3.4) days]. At 1-year follow-up, more patients maintained target glycaemia without any drugs in the oral drug + insulin group than in the oral drug group [37.9% (22 of 58) vs 20.9% (14 of 67)]. Both treatments improved homeostasis model assessment-β (HOMA-β) and homeostasis model assessment-insulin resistance (HOMA-IR) significantly. They had similar effects on insulin resistance [lg(HOMA-IR): (0.50 ± 0.09) vs (0.48 ± 0.09), p = 0.23]. However, oral drugs + insulin could recover β-cell function much more than OAD alone could [lg(HOMA-β): (2.17 ± 0.14) vs (2.11 ± 0.13), p = 0.03].
  
  
  CONCLUSIONS
  In newly diagnosed type 2 diabetes, therapy with oral drugs + insulin has had favourable outcomes on recovery and maintenance of β-cell function and protracted glycaemic remission compared with treatment with oral drugs alone.
authors: Department of Endocrinology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors: Pan-wei
authors: PW
authors: Mu
authors: Yan-ming
authors: YM
authors: Chen
authors: Hong-yun
authors: HY
authors: Lu
authors: Xing-qiao
authors: XQ
authors: Wen
authors: Yan-hua
authors: YH
authors: Zhang
authors: Ru-ying
authors: RY
authors: Xie
authors: Jiong
authors: J
authors: Shu
authors: Man-man
authors: MM
authors: Wang
authors: Long-yi
authors: LY
authors: Zeng
mesh_terms: D000284:Administration, Oral; D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006706:Homeostasis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D007333:Insulin Resistance / Q000502:physiology; D050417:Insulin-Secreting Cells / Q000187:drug effects*; D008297:Male; D008687:Metformin / Q000008:administration & dosage; D008875:Middle Aged; D008954:Models, Biological; D013453:Sulfonylurea Compounds / Q000008:administration & dosage
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D013453:Sulfonylurea Compounds; C057619:glimepiride; D008687:Metformin