ADA 2021 Roundup: SoliMix Trial; Byetta for Teens; Driving in Hypoglycemia

Some of the latest research advancements in the field of diabetes presented at the American Diabetes Association (ADA) virtual meeting included the long-awaited GRADE findings, heart and renal outcomes with an investigational GLP-1 receptor agonist, and HbA1c efficacy with a new combination GIP/GLP-1 receptor agonist.

Below are a few more research highlights.

SoliMix Trial

When managing type 2 diabetes, the once-daily iGlarLixi (Soliqua) edged out the twice-daily premix insulin analog BIAsp 30, according to the SoliMix trial.

The 26-week, open-label trial included adults with poorly controlled type 2 diabetes, defined as a baseline HbA1c between 7.5% and 10%. All participants were on basal insulin, as well as oral antidiabetic agents.

Approved in 2016, iGlarLixi is a fixed-ratio combination of insulin glargine 100 U/mL (iGlar) and the GLP-1 receptor agonist lixisenatide (Lixi). BIAsp 30 is biphasic insulin aspart 30/70, and is a premixed injectable insulin analogue with 30% soluble, rapid-acting insulin aspart plus 70% intermediate-acting protamine-bound aspart.

By the end of the head-to-head trial, those on iGlarLixi saw an average drop in HbA1c of 1.3% compared with a 1.1% drop seen with BIAsp 30 (least squares mean difference -0.2, 97.5% CI -0.4 to -0.1%, P<0.001), reported Julio Rosenstock, MD, of the Dallas Diabetes and Endocrine Center, and colleagues. The findings were simultaneously published in Diabetes Care.

Beyond HbA1c reduction, iGlarLixi was superior when it came to weight loss, as these participants saw an average 1.9 kg (4.2 lbs) greater reduction in body weight versus BIAsp 30. Significantly more patients on iGlarLixi achieved a target HbA1c below 7% without weight gain and without hypoglycemia. Additionally, rates of hypoglycemia were lower with iGlarLixi.

Exenatide for Teens

Once weekly exenatide (Byetta, Bydureon) was superior to placebo in reducing HbA1c in youth with type 2 diabetes, found William Tamborlane, MD, of Yale School of Medicine in New Haven, Connecticut, and colleagues.

According to the late-breaking, pivotal phase III, randomized study, youth on the GLP-1 receptor agonist saw a 0.36% drop in HbA1c after 24 weeks versus a 0.49% rise in those on placebo (between-group difference -0.85%, P=0.012). Although not reaching statistical significance, there was a trend toward better outcomes for fasting glucose (-21.6 mg/dL, 95% CI -49.0 to 5.7, P=0.119), body weight (-1.22 kg, 95% CI -3.59 to 1.15, P=0.307), and systolic blood pressure (-2.8 mmHg, 95% CI -8.0 to 2.4, P=0.284) seen with active exenatide.

The trial included 83 participants, ages 10 to 17 years, whose type 2 diabetes was poorly controlled with other treatments. Of the 59 participants assigned to the treatment arm, they were administered 2 mg of once-weekly exenatide.

Exenatide is currently approved for use in adults with type 2 diabetes as adjunct to diet and exercise. However, the FDA granted AstraZeneca a priority review for its supplemental new drug application for the use of exenatide in adolescents, ages 10 to 17 years.

Hypoglycemia Behind the Wheel

A machine-learning gaze analysis was able to accurately gauge when drivers were experiencing hypoglycemia.

The late-breaking study of 19 individuals with type 1 diabetes found the machine-learning analysis accurately detected hypoglycemia with an area under the receiver operating characteristics curve of 0.83. This was based upon nearly 30,000 data samples (about 1,600 per participant) around 10,000 of which were during euglycemia and 20,000 of which during an episode of hypoglycemia.

During these study-induced episodes of hypoglycemia, average blood glucose levels started at 105.4 mg/dL in the first session, then dropped from 61.4 mg/dL to 47.2 mg/dL during session two, and ended at 42.7 mg/dL during session three. Each of the three sessions lasted 18 minutes in duration, and both gaze and blood glucose data was collected while the participant was operating a driving similar.

"Our approach offers promising potential in various settings where cameras are available," said Vera Lehmann, MD, of Bern University Hospital in Switzerland, said during a poster presentation.