META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS OF LIXISENATIDE AS ADD-ON TO BASAL INSULIN ± OADs IN PATIENTS WITH TYPE 2 DIABETES MELLITUS — ASN Events

META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS OF LIXISENATIDE AS ADD-ON TO BASAL INSULIN ± OADs IN PATIENTS WITH TYPE 2 DIABETES MELLITUS (#368)

David O'Neal 1 , Bernard Charbonnel 2 , Edward Wang 3 , Jay Lin 4 , Melanie J. Davies 5 , Vivian Fonseca 6
  1. St Vincent\'s Hospital (Melbourne), Fitzroy, Vic, Australia
  2. University of Nantes, Clinique d’Endocrinologie, Nantes, France
  3. Diabetes-Metabolism Franchise , Sanofi-Aventis, Bridgewater, NJ, USA
  4. Outcomes Research, Novosys Health, Flemington, NJ, USA
  5. University of Leicester, Leicester, UK
  6. Tulane University Health Sciences Center, New Orleans, LA, USA
The safety and efficacy of lixisenatide (LIXI), a new once-daily prandial glucagon-like peptide-1 receptor agonist, has been evaluated as add-on to basal insulin ± oral antidiabetic drugs (OADs) in three Phase III, randomized, placebo (PBO)-controlled trials (GetGoal-L, -Duo1 and -L Asia) in Type 2 diabetes mellitus (T2DM). Endpoints included glycated hemoglobin (HbA1c), weight, insulin dose, fasting blood glucose, postprandial glucose and hypoglycemia. A meta-analysis was performed on the safety and efficacy outcomes in 1198 patients (mean age: 57.2 yrs; diabetes duration: 11.7 yrs; Body Mass Index: 30.3 kg/m2) enrolled to these trials, using a random effects model (RevMan). A significantly higher proportion of LIXI-treated patients achieved HbA1c<7% vs PBO (odds ratio [OR] 3.67, confidence interval [CI] 1.64, 8.19; p=0.002). Furthermore, LIXI was more than 3´ as likely to result in HbA1c<7% and no weight gain (OR 3.35, CI 1.66, 6.77; p=0.0008), and more than 2.5 times as likely to result in either: i) HbA1c<7% + no documented symptomatic hypoglycemia (OR 2.65, CI 1.30, 5.38; p=0.007); or ii) HbA1c<7% + no weight gain + no documented symptomatic hypoglycemia (OR 2.64, CI 1.48, 4.70; p=0.0009) (Table). In patients with T2DM, LIXI as add-on to basal insulin ± OADs is significantly more effective than PBO in achieving HbA1c <7%, and is more than 2.5´ as likely to result in HbA1c<7% with no documented hypoglycemia and no weight gain; it is, therefore, an attractive potential option as add-on to treatment with basal insulin.

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