Studies presented at the 77th Scientific Sessions of the American Diabetes Association show that the combination therapy helps patients with the highest glycated hemoglobin levels gain control quickly.
In January, Sanofi won the battle to be first in the US market with a fixed-dose combination of insulin and glucagon-like peptide-1 (GLP-1) receptor agonist, and presentations at this weekend’s 77th Scientific Sessions of the American Diabetes Association (ADA) added to the evidence of the benefits of this novel therapy for type 2 diabetes (T2D).
New results gleaned from the LixiLan-O and LixiLan-L phase 3 clinical trials to show the injectible, sold as Soliqua, can help those with the highest glycated hemoglobin (A1C) levels gain control quickly, with less risk of hypoglycemia or weight gain—and, most critically, without having to first try insulin alone.
In an interview with The American Journal of Managed Care®, Rachele Berria, MD, PhD, vice president and head of the Diabetes Medical Unit for Sanofi, summarized where diabetes therapy has been before the arrival of the fixed-dose insulin GLP-1 combinations (the other being Novo Nordisk’s Xultophy). Berria said with the arrival of GLP-1 class following the dipeptidyl peptidase 4 inhibitors, there was a risk of overpromising patients they would lose weight, and it’s important to be realistic about what therapies can do.
Still, today’s therapies are a step forward over using insulin alone, when the prospect of weight gain caused many patients to balk at intensifying therapy. “With that one injection,” Berria said, the patient can not only achieve better glycemic control, but also see a positive effect on body weight. The gastrointestinal side effects seen in a GLP-1 therapy are mitigated.
As far back as the Diabetes Control and Complications Trial (DCCT), researchers gained an understanding of the benefit of early intensification of therapy and better diabetes management, but in the real world it didn’t always happen, Berria said. “Letting them go and fall off track will, of course, lead to deleterious consequences,” she said.
The task is to avoid that clinical inertia, which lets patients try for another 3 months, or another 6 months to get their A1C lower, instead of being proactive to gain control. This is where a fixed-dose combination therapy like Soliqua can help, Berria said.
“You have the opportunity of titrating it slowly as you would with insulin,” she said. “This makes it easier for patients to intensify therapy.”
“The key is to know when it’s time to do more,” she said. Here, there’s a lot of education to do with clinicians.
Studies involving iGlarLixi (Soliqua) at this week’s ADA Scientific Sessions include:
1. Niemoeller E, Souhami E, Wu Y, Jensen KH. iGlarLixi reduces A1C to a greater extent than basal insulin therapy regardless of A1C levels at screening. Presented at the 77th Scientific Sessions of the American Diabetes Association, June 9-13, 2017, San Diego, California; abstract 1079-P.
2. Frias JP, Domingo MP, Meneghini LF, et al. Shorter time to glycemic control with fixed-ratio combination of insulin glargine and lixisenatide compared with insulin glargine treatment alone. Presented at the 77th Scientific Sessions of the American Diabetes Association, June 9-13, 2017, San Diego, California; abstract 1084-P.
3. Russell-Jones D, McCrimmon RJ, Barder TM, Baradez C, Baxter MA, Davies M. iGlarLixi fixed-ratio combination vs insulin glargine and lixisenatide in patients with T2DM treated previously with two oral antidiabetics: LixiLan-O subgroup analysis. Presented at the 77th Scientific Sessions of the American Diabetes Association, June 9-13, 2017, San Diego, California; abstract 134-LB.
4. Davies M, Russell-Jones D, Barber TM, Baradez C, Baxter MA, McCrimmon RJ. iGlarLixi fixed-ratio combination in patients with HbA1C >9%: LixiLan-O subgroup analysis. Presented at the 77th Scientific Sessions of the American Diabetes Association, June 9-13, 2017, San Diego, California; abstract 137-LB.