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Insulin glargine, lixisenatide combination safe, effective for older adults with type 2 diabetes
A single injection combination of basal insulin glargine and lixisenatide known as iGlarLixi improves glycemic control without increasing the risk for severe hypoglycemia in older adults with type 2 diabetes, according to findings published in the Journal of Diabetes and its Complications.
“We have a limited number of safe treatments for people above [age] 65 [years]. IGlarLixi provides significant improvements in glycemic control in patients aged [at least] 65 years without increasing hypoglycemia risk,” Yehuda Handelsman, MD, FACP, FNLA, FASPC, MACE MD, medical director and principal investigator of the Metabolic Institute of America, and Endocrine Today Editorial Board Member, said in an interview. “As a once-daily injection, it simplifies treatment regimens and may contribute to improved adherence in this patient population.”
Handelsman and colleagues conducted a post hoc analysis of two randomized phase 3 trials of iGlarLixi (Soliqua, Sanofi). In the first, participants were randomly assigned to treatment with iGlarLixi or basal insulin glargine alone for 30 weeks (LixiLan-L). In the second, participants were treated with either iGlarLixi, basal insulin glargine or lixisenatide for 30 weeks (LixiLan-O). The researchers extrapolated data from both trials focusing solely on participants aged at least 65 years (n = 534), using HbA1c, fasting plasma glucose, postprandial glucose, weight and the proportion of participants achieving HbA1c less than 7% as efficacy endpoints and severe hypoglycemia and gastrointestinal adverse effects as safety endpoints.
In the LixiLan-L study, participants who were treated with iGlarLixi (n = 110) achieved a greater reduction in HbA1c vs. participants receiving basal insulin glargine alone (n = 119; P < .001). The iGlarLixi group also had greater reductions of FPG and postprandial glucose (P < .001), and superior HbA1c reduction at weeks 8 (HbA1c levels of 7.3% vs. 7.7%), 12 (HbA1c levels of 7.1% vs. 7.7%), 24 (HbA1c levels of 6.9% vs. 7.6%) and 30 (HbA1c levels of 7 vs. 7.6%).
The LixiLan-O trial had similar results. Compared with basal insulin glargine (n = 114) or lixisenatide (n = 58) alone, participants who received iGlarLixi (n = 132) had significantly greater reductions in HbA1c and FPG vs. those in the lixisenatide group. The iGlarLixi group decreased HbA1c levels to 6.5% at week 30 of the trial compared with levels of 6.9% and 7.2% in the basal insulin glargine and lixisenatide groups, respectively. Like the LixiLan-L trial, the LixiLan-O trial revealed a better reduction in postprandial glucose in the iGlarLixi group vs. basal insulin glargine alone (P < .001).
Across both studies, more participants in the iGlarLixi groups reached HbA1c levels of less than 7% than those in the insulin groups (51.8% vs. 21% in LixiLan-L and 78% vs. 54.4% in LixiLan-O) and those in the lixisenatide group (78% vs. 39.7%; P < .001 for all comparisons).
In both trials, the participants receiving iGlarLixi also lost more weight than those taking basal insulin glargine alone (–1.2 kg vs. 0.6 kg in LixiLan-L and –0.9 kg vs. +1.2 kg in LixiLan-O; P < .001 for both).
Symptomatic hypoglycemia occurrence was lower in the iGlarLixi groups of both trials in comparison with the basal insulin glargine groups (36.4% vs. 43.7% in LixiLan-L; 27.8% vs. 28.9% in LixiLan-O). However, lixisenatide resulted in lower rates of hypoglycemia (3.4%). In addition, both iGlarLixi and basal insulin glargine were associated with significantly fewer gastrointestinal adverse events compared with lixisenatide.
“It is advisable that agents with a lower risk of hypoglycemia are considered for older patients trying to achieve glycemic goals: Hypoglycemia is of particular concern in this population, as it is often overlooked or not reported to clinicians,” the researchers wrote. “Therefore, when choosing treatment for older patients with type 2 diabetes, balancing the benefits of glycemic control against the potential harms and burdens of treatment is of particular importance.” – by Phil Neuffer
For more information:
Yehuda Handelsman, MD, FACP, FNLA, FASPC, MACE MD, can be reached at the Metabolic Institute of America, 18372 Clark St., Tarzana, CA 913561; email: yhandelsman@gmail.com
Disclosures: The study was supported by Sanofi. Handelsman reports he received research support from, was a member of the speakers bureau or was an author for Aegerion, Amarin Pharma, Amgen, AstraZeneca, Boehringer Ingelheim, Boehringer Ingelheim-Lilly, Bristol-Myers Squibb, Gan & Lee, Gilead, Grifolis, Hanmi, Intarcia, Janssen, Lexicon Pharmaceuticals, Lilly, Merck, Merck-Pfizer, Mylan, Novo Nordisk, Regeneron and Sanofi. Please see the study for all other authors’ relevant financial disclosures.