RT Journal Article
SR Electronic
T1 Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial
JF Diabetes Care
JO Diabetes Care
FD American Diabetes Association
SP 485
OP 493
DO 10.2337/dc16-2143
VO 40
IS 4
A1 Meneilly, Graydon S.
A1 Roy-Duval, Christine
A1 Alawi, Hasan
A1 Dailey, George
A1 Bellido, Diego
A1 Trescoli, Carlos
A1 Manrique Hurtado, Helard
A1 Guo, Hailing
A1 Pilorget, Valerie
A1 Perfetti, Riccardo
A1 Simpson, Hamish
YR 2017
UL http://care.diabetesjournals.org/content/40/4/485.abstract
AB 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 μg 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 HbA1c 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. HbA1c decreased substantially with lixisenatide (−0.57% [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 HbA1c reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.