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Title: Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Authors: Rosenstock, Julio
Guerci, Bruno
Hanefeld, Markolf
Gentile, Sandro
Aronson, Ronnie
Tinahones, Francisco J
Roy-Duval, Christine
Souhami, Elisabeth
Wardecki, Marek
Ye, Jenny
Perfetti, Riccardo
Heller, Simon
GetGoal Duo-2 Trial Investigators
metadata.dc.subject.mesh: Aged
Blood Glucose
Body Mass Index
Body Weight
Diabetes Mellitus, Type 2
Drug Therapy, Combination
Endpoint Determination
Glucagon-Like Peptide-1 Receptor
Glycated Hemoglobin
Hypoglycemic Agents
Insulin Glargine
Middle Aged
Postprandial Period
Issue Date: 23-May-2016
Abstract: To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs). Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization. Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound Baseline characteristics were similar between arms (n = 298, diabetes and basal insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m(2)). HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met. Symptomatic hypoglycemia and body weight were lower in lixisenatide versus glulisine patients. More gastrointestinal events occurred with lixisenatide. Short-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin may become a preferred treatment intensification option, attaining meaningful glycemic targets with fewer hypoglycemic events without weight gain versus basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes.
metadata.dc.identifier.doi: 10.2337/dc16-0014
Appears in Collections:Producción 2020

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