HealthDay News — For patients with uncontrolled type 2 diabetes, a fixed ratio of insulin degludec/liraglutide is noninferior to continued titration of insulin glargine, according to a study published in the March 1 issue of the Journal of the American Medical Association.
Ildiko Lingvay, MD, MPH, from the University of Texas Southwestern Medical Center in Dallas, and colleagues conducted a phase 3, 26-week trial at 76 centers in 10 countries involving 557 patients with uncontrolled diabetes. Participants were treated with glargine and metformin and had glycated hemoglobin (HbA1c) levels of 7% to 10%. They were randomly allocated to degludec/liraglutide (278 patients) or glargine (279 patients), with twice-weekly titration to a glucose target of 72 to 90 mg/dL
The researchers found that the HbA1c level reduction was greater with degludec/liraglutide than glargine (−1.81% versus −1.13%), meeting the criteria for noninferiority and superiority (both P < 0.001). Compared with glargine, treatment with degludec/liraglutide correlated with weight loss (versus weight gain) and fewer confirmed hypoglycemic episodes. The groups had similar rates of overall and serious adverse events, although more nonserious gastrointestinal adverse events were reported with degludec/liraglutide.
“Treatment with degludec/liraglutide compared with up-titration of glargine resulted in noninferior HbA1c levels, with secondary analyses indicating greater HbA1c level reduction after 26 weeks of treatment,” the authors write.
Several authors disclosed financial ties to the biopharmaceutical industry.
- Lingvay I, Pérez Manghi F, García-Hernández P, et al. Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients with Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. JAMA. 2016;315(9):898-907; doi: 10.1001/jama.2016.1252