Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial
Por:
Meneilly GS, Roy-Duval C, Alawi H, Dailey G, Bellido D, Trescoli C, Manrique Hurtado H, Guo H, Pilorget V, Perfetti R, Simpson H and GetGoal-O Trial Investigators
Publicada:
1 abr 2017
Resumen:
OBJECTIVE
To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment.
RESEARCH DESIGN AND METHODS
In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged >= 70 years were randomized to receive once-daily lixisenatide 20 mu g or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA(1c) from baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight.
RESULTS
A total of 350 patients were randomized. HbA(1c) decreased substantially with lixisenatide (20.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P < 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (-5.12 mmol/L) than with placebo (-0.07 mmol/L; P < 0.0001). A greater decrease in body weight was observed with lixisenatide (-1.47 kg) versus placebo (-0.16 kg; P < 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo.
CONCLUSIONS
In nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA(1c) reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.
Filiaciones:
Meneilly GS:
University of British Columbia, Vancouver, British Columbia, Canada
Roy-Duval C:
Sanofi, Chilly-Mazarin, France
Alawi H:
Diabetessaar-Center, Saarlouis, Germany
Dailey G:
Scripps Whittier Diabetes Institute, La Jolla, CA
Bellido D:
University Hospital of Ferrol, Ferrol (Galicia), Spain
:
Hospital de la Ribera, Alzira, Spain
Manrique Hurtado H:
Centro de Investigación en Diabetes, Obesidad y Nutrición, Lima, Peru
Guo H:
BMD Consulting, Inc., Somerset, NJ
Pilorget V:
Sanofi, Chilly-Mazarin, France
Perfetti R:
Sanofi, Bridgewater, NJ
Simpson H:
Townhead Surgery, Irvine, U.K
Bronze
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