Efficacy and safety of the insulin glargine plus lixisenatide fixed-ratio combination vs. insulin glargine in patients wth T2DM: the LixiLan-L trial [abstract] Abstract uri icon
Overview
abstract
  • LixiLan is a fi xed-ratio combination of insulin glargine (Gla100) and the GLP-1 RA lixisenatide, currently in development for the management of T2DM. This open-label trial compared the efficacy and safety of LixiLan with Gla100 over 30 weeks. Patients were inadequately controlled on basal insulin, alone, or with up to 2 oral antidiabetic drugs. In a 6-week run-in phase, Gla100 was introduced or optimized. Patients whose HbA1c remained >7% (n=736), despite FPG < 140 mg/dL after run-in, were then randomized to LixiLan or Gla100. From screening to baseline (post run-in) mean HbA1c fell from 8.5% to 8.1%. At week 30, the LixiLan group showed a statistically superior reduction from baseline HbA1c, compared with Gla100 (-1.1% vs. -0.6%, p<0.0001). In total, 55% of LixiLan patients reached HbA1c <7% compared with 30% of Gla100 patients. Body weight decreased by 0.7 kg in the LixiLan group and increased by 0.7 kg in the Gla100 group (difference 1.4 kg, p<0.0001). The rate of documented ( < 70 mg/dL and < 60 mg/dL) symptomatic hypoglycemia was comparable between groups. Both treatments were well tolerated. In conclusion, LixiLan showed superior glycemic control to Gla100 (Table), with a beneficial effect on body weight, no additional risk of hypoglycemia and a low rate of nausea and vomiting in patients with long-standing T2DM uncontrolled on basal insulin. RA lixisenatide, currently in development for the management of T2DM. This open-label trial compared the efficacy and safety of LixiLan with Gla100 over 30 weeks. Patients were inadequately controlled on basal insulin, alone, or with up to 2 oral antidiabetic drugs. In a 6-week run-in phase, Gla100 was introduced or optimized. Patients whose HbA1c remained >7% (n=736), despite FPG

  • publication date
  • 2016
  • published in
  • Diabetes  Journal
  • Research
    keywords
  • Diabetes
  • Drugs and Drug Therapy
  • Randomized Controlled Trials
  • Additional Document Info
    volume
  • 65
  • issue
  • Suppl 1