RT Journal Article
SR Electronic
T1 Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial
JF Diabetes Care
JO Diabetes Care
FD American Diabetes Association
SP 1009
OP 1016
DO 10.2337/dc17-1114
VO 41
IS 5
A1 Billings, Liana K.
A1 Doshi, Ankur
A1 Gouet, Didier
A1 Oviedo, Alejandra
A1 Rodbard, Helena W.
A1 Tentolouris, Nikolaos
A1 Grøn, Randi
A1 Halladin, Natalie
A1 Jodar, Esteban
YR 2018
UL http://care.diabetesjournals.org/content/41/5/1009.abstract
AB OBJECTIVE In patients with uncontrolled type 2 diabetes on basal insulin, prandial insulin may be initiated. We assessed the efficacy and safety of initiating insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus basal-bolus insulin.RESEARCH DESIGN AND METHODS A phase 3b trial examined patients with uncontrolled type 2 diabetes on insulin glargine (IGlar U100) 20–50 units/day and metformin, randomized to IDegLira or IGlar U100 and insulin aspart ≤4 times per day.RESULTS Glycated hemoglobin (HbA1c) decreased from 8.2% (66 mmol/mol) to 6.7% (50 mmol/mol) with IDegLira and from 8.2% (67 mmol/mol) to 6.7% (50 mmol/mol) with basal-bolus (estimated treatment difference [ETD] −0.02% [95% CI −0.16, 0.12]; −0.2 mmol/mol [95% CI −1.7, 1.3]), confirming IDegLira noninferiority versus basal-bolus (P < 0.0001). The number of severe or blood glucose–confirmed symptomatic hypoglycemia events was lower with IDegLira versus basal-bolus (risk ratio 0.39 [95% CI 0.29, 0.51]; rate ratio 0.11 [95% CI 0.08, 0.17]). Body weight decreased with IDegLira and increased with basal-bolus (ETD −3.6 kg [95% CI −4.2, −2.9]). Fasting plasma glucose reductions were similar; lunch, dinner, and bedtime self-monitored plasma glucose measurements were significantly lower with basal-bolus. Sixty-six percent of patients on IDegLira vs. 67.0% on basal-bolus achieved HbA1c <7.0% (53 mmol/mol). Total daily insulin dose was lower with IDegLira (40 units) than basal-bolus (84 units total; 52 units basal).CONCLUSIONS In patients with uncontrolled type 2 diabetes on IGlar U100 and metformin, IDegLira treatment elicited HbA1c reductions comparable to basal-bolus, with statistically superior lower hypoglycemia rates and weight loss versus weight gain.