Uncontrolled Type 2 Diabetes and Degludec/Liraglutide Fixed-Ratio Combination
Safety, Efficacy of Degludec/Liraglutide Fixed-Ratio Combination in Uncontrolled T2D
Billings LK, Doshi A, Gouet D, et al. Efficacy and safety of IDegLira versus basal-bolus insulin therapy in patients with type 2 diabetes uncontrolled on metformin and basal insulin; DUAL VII randomized clinical trial [published online February 26, 2018]. Diabetes Care. doi: 10.2337/dc17-1114
In patients with uncontrolled type 2 diabetes receiving basal insulin and metformin, treatment with insulin degludec/liraglutide fixed-ratio combination (IDegLira) may reduce glycated hemoglobin (HbA1c) levels comparable to those of basal-bolus insulin with lower hypoglycemia rates and weight loss vs weight gain, according to a phase 3b, multinational, open-label study published in Diabetes Care.
In the first trial to compare the efficacy and safety of a fixed-ratio combination of basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1RA) with basal-bolus insulin, researchers randomly assigned 506 patients with uncontrolled type 2 diabetes receiving insulin glargine to 50 units/day and metformin to receive either IDegLira or insulin glargine and insulin aspart 4 or fewer times a day.
After 26 weeks of treatment, HbA1c decreased from 8.2% (66 mmol/mol) to 6.7% (50 mmol/mol) in patients taking IDegLira and from 8.2% (67 mmol/mol) to 6.7% (50 mmol/mol) in patients taking basal-bolus insulin, confirming IDegLira noninferiority vs basal-bolus insulin (P <.0001). In addition, 66% of patients taking IDegLira compared with 67% of patients taking basal-bolus insulin achieved an HbA1c <7.0% (53 mmol/mol).
Fasting plasma glucose reductions were similar between the groups, but lunch, dinner, and bedtime self-monitored plasma glucose measurements were significantly lower for patients taking basal-bolus insulin.
The total daily insulin dose was found to be lower in the IDegLira group (40 units) than in the basal-bolus insulin group (84 units total; 52 units basal), as well as the incidence of severe or blood glucose-confirmed symptomatic hypoglycemia events. In addition, body weight decreased for patients in the IDegLira group and increased for patients in the basal-bolus insulin group.
The authors concluded that "compared with basal-bolus, IDegLira offers an alternative well-tolerated treatment with fewer injections, doses taken independently of meals, lower total daily insulin dose, reduced monitoring, weight loss, and reduced rate of hypoglycemic episodes."