Two Insulin Regimens Compared in Uncontrolled T2DM Patients

The results come from a Phase 3 trial by researchers at the University of North Carolina
The results come from a Phase 3 trial by researchers at the University of North Carolina

Greater HbA1c reduction was seen with insulin degludec/liraglutide vs. insulin glargine, meeting the criteria for noninferiority, according to a study published in JAMA.

Study authors from the University of North Carolina School of Medicine conducted a Phase 3, multinational, multicenter, 26-week randomized, open-label, treat-to-target trial. They compared outcomes of once-daily basal insulin titrated (glargine) vs. once-daily basal insulin degludec and liraglutide, a glucagon-like peptide-1 receptor agonist, in 557 patients with uncontrolled type 2 diabetes. Patients were previously treated with glargine and metformin (≥1500mg daily) with HbA1c levels of 7–10% and a body mass index (BMI) of ≤40.

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Primary outcome measures were change in HbA1c after 26 weeks with a noninferiority margin of 0.3%. Secondary endpoints were tested for statistical superiority, including changes in HbA1c level, change in body weight, and rate of confirmed hypoglycemic episodes. 

Reduction in HbA1c level was greater with insulin degludec/liraglutide vs. insulin glargine (-1.81% vs. -1.13%, 95% CI: -0.74% to -0.45%), which met the criteria for noninferiority (P<0.001) and statistical superiority (P<0.001). 

Additional analyses showed weight loss associated with insulin degludec/liraglutide (-1.4kg) vs. weight gain seen with insulin glargine (+1.8kg). Further, treatment with insulin degludec/liraglutide was associated with a lower rate of hypoglycemia (estimated rate ratio 0.43, 95% CI: 0.30-0.61; P<0.001). Regarding adverse events, rates of overall and serious events were similar between the 2 treatment arms. However, more nonserious gastrointestinal adverse events were reported with degludec/liraglutide. 

Researcher John B. Buse, MD, PhD, added that more research is needed to study the durability of effects of insulin degludec/liraglutide in longer-term studies, and to see whether patients and clinicians consider it a suitable option "to overcome barriers to treatment intensification." 

For more information visit jamanetwork.com.

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