medwireNews: Results of the placebo-controlled GetGoal-O trial suggest that adding lixisenatide to existing diabetes treatment improves glycemic control among nonfrail older patients with uncontrolled type 2 diabetes.
Therefore, the glucagon-like peptide-1 (GLP-1) agonist “can be considered a valuable option” for this group of patients, say Graydon Meneilly (University of British Columbia, Vancouver, Canada) and study co-authors.
In the phase III trial, patients aged 70 years or older who had type 2 diabetes inadequately controlled with their current treatment regimen were randomly assigned to receive once-daily lixisenatide 20 µg or placebo by self-injection before breakfast, alongside their existing diabetes treatment.
Glycated hemoglobin (HbA1c) levels decreased from a mean of 8.03% at baseline to 7.36% at week 24 among 175 patients receiving lixisenatide, compared with corresponding measurements of 8.05% and 8.01% among 173 patients in the placebo group.
These results translate into a significant least squares mean (LSM) difference of 0.64%, demonstrating the superiority of lixisenatide versus placebo for HbA1c change over the study period, report the authors in Diabetes Care.
The team also observed a greater decrease in bodyweight among patients receiving lixisenatide, with measurements of 80.76 kg at baseline and 79.13 kg at week 24 versus a respective 80.24 kg and 79.99 kg in the placebo group, giving a significant LSM difference of 1.32 kg.
Weight loss associated with GLP-1 agonists “often is advantageous in mitigating the weight-gain effect of insulin therapy,” note the authors, but they caution that “weight loss can be detrimental” in frail underweight older patients, who were excluded from the trial.
Although “similar proportions” of patients in the lixisenatide and placebo groups reported treatment-emergent adverse events (71.0 vs 67.8%), nausea and vomiting were both reported more frequently by patients receiving lixisenatide (25.0 vs 7.5% and 5.7 vs 0.6%, respectively). In all, 5.7% of patients receiving lixisenatide discontinued treatment due to gastrointestinal adverse events, compared with 0.6% of those in the placebo group.
Furthermore, a higher proportion of participants receiving lixisenatide than placebo experienced hypoglycemia (17.6 vs 10.3%), “possibly because of a higher incidence of hypoglycemia in patients receiving lixisenatide plus a sulfonylurea,” say the authors.
Meneilly and colleagues caution that the GetGoal-O trial was limited by the exclusion of “[n]umerous subtypes of the older population,” such as people at risk for malnutrition and those with cognitive impairments.
Nevertheless, they believe that “[p]atient age and characteristics make these results highly relevant to clinical practice, providing valuable evidence for the treatment of older, complex patients with type 2 diabetes.”
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