A daily injection of combination degludec/liraglutide led to greater HbA1c reduction than an increase in daily Lantus dose in patients with uncontrolled type 2 diabetes, according to results of the DUAL V trial published in JAMA.
John B. Buse, MD, PhD, professor of medicine at the University of North Carolina School of Medicine, and colleagues evaluated 557 patients with uncontrolled type 2 diabetes treated with Lantus (insulin glargine 100 units/mL, Sanofi Aventis; 20-50 U) and metformin ( 1,500 mg/dL) who had HbA1c levels of 7% to 10% from 75 centers in 10 countries from September 2013 to November 2014.
John B. Buse
Participants were randomly assigned degludec/liraglutide (n = 278; maximum dose, 50 U degludec and 1.8 mg liraglutide) or glargine (n = 279; no maximum dose) with twice-weekly titration to a glucose target of 72 mg/dL to 90 mg/dL to determine whether degludec/liraglutide is noninferior to up-titration of glargine.
Mean baseline HbA1c was 8.4% in the degludec/liraglutide group and 8.2% in the glargine group and decreased more in the degludec/liraglutide group (–1.81%) after 26 weeks compared with the glargine group (–1.13%; meeting criteria for noninferiority, P < .001; meeting criteria for statistical superiority, P < .001). Mean weight loss in the degludec/liraglutide group was 1.4 kg compared with a mean 1.8-kg weight increase in the glargine group.
Both groups had similar overall and serious adverse event rates. Fewer patients in the degludec/liraglutide group had confirmed hypoglycemic events compared with the glargine group (28.4% vs. 49.1%).
“Among patients with uncontrolled type 2 diabetes taking glargine and metformin, treatment with degludec/liraglutide compared with up-titration of glargine results in noninferior HbA1c levels, with secondary analyses indicating greater HbA1c level reduction after 26 weeks of treatment,” the researchers wrote. “Further studies are needed to assess longer-term efficacy and safety.”
The degludec/liraglutide combination is available in Europe under the brand name Xultophy (Novo Nordisk). – by Amber Cox
Buse reports various financial ties with Andromeda, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Dance Biopharm, Elcelyx, Eli Lilly, GI Dynamics, GlaxoSmithKline, Halozyme Therapeutics, Intarcia Therapeutics, Johnson & Johnson, Lexicon, MacroGenics, Medtronic, Merck, Metavention, Minimed, Novo Nordisk, Orexigen, Osiris, PhaseBio, Quest, Sanofi, Scion NeuroStim, Takeda, Tolerex and vTv Therapeutics. Please see the full study for a list of all other authors’ relevant financial disclosures.