Adults with uncontrolled type 2 diabetes treated with a fixed-ratio combination of insulin degludec and liraglutide, or IDegLira, experienced lower rates of hypoglycemia compared with those treated with insulin glargine 100 U/mL and insulin aspart, study data show.
Further, those treated with IDegLira (Xultophy 100/3.6, Novo Nordisk) experienced weight loss, whereas those assigned to insulin glargine U100 (Lantus, Sanofi) and insulin aspart gained weight, according to the researchers.
Liana K. Billings, MD, of the NorthShore University HealthSystem in Evanston, Chicago, and the University of Chicago Pritzker School of Medicine, and colleagues evaluated data from the DUAL VII randomized clinical trial on 506 adults with uncontrolled type 2 diabetes prescribed insulin glargine U100 and metformin. Researchers sought to determine the safety and efficacy of IDegLira (n = 252; 43.7% men; mean age, 58.6 years) vs. insulin glargine U100 and insulin aspart up to four times a day (basal-bolus insulin; n = 254; 46.1% men; mean age, 58 years). The study included a 2-week screening period, a 26-week treatment period and a 4-week follow-up period.
Mean HbA1c decreased from 8.2% at baseline to 6.7% at the end of the study period for both groups, demonstrating noninferiority of IDegLira vs. basal-bolus insulin (P < .0001).
During the treatment period, one or more treatment emergent severe or blood glucose confirmed symptomatic hypoglycemic episodes was experienced by 19.8% of the IDegLira group and 52.6% of the basal-bolus group corresponding to a 61% lower risk with IDegLira compared with basal-bolus insulin (P < .0001). The confirmatory analyses of number of treatment emergent or blood glucose confirmed symptomatic hypoglycemic episodes revealed 89% lower risk for IDegLira compared with basal bolus insulin. There was a 34% lower risk and 72% lower rate of severe hypoglycemia with IDegLira compared with basal bolus insulin, but the number of severe episodes was generally low. Mean body weight decreased by 0.9 kg with IDegLira compared with a 2.6-kg weight increase with basal-bolus insulin (P < .0001).
There was a a 75% lower risk for and 92% rate reduction in nocturnal hypoglycemia with IDegLira compared with basal-bolus insulin (P < .0001 for both).
Participants assigned to IDegLira had greater odds for reaching the HbA1c target of less than 7% without hypoglycemic episodes and weight gain compared with the basal-bolus group (P < .0001).
“This is the only trial thus far that compared a fixed-ratio combination of basal insulin and GLP-1 [receptor agonist] with basal-bolus,” the researchers wrote. “With once-daily vs. multiple daily injections, IDegLira was noninferior to basal-bolus with respect to HbA1c reduction and statistically superior with respect to lower hypoglycemia rate and change in body weight in patients on [insulin glargine] U100 and metformin with uncontrolled [blood glucose].” – by Amber Cox
Disclosures: Billings reports she has participated in advisory panels for and is on the speakers bureau for Novo Nordisk. Please see the study for all other authors’ relevant financial disclosures.