Περίληψη:
Background: Insulin degludec/liraglutide (IDegLira) results in glycated hemoglobin (HbA1c) levels comparable with basal-bolus (BB) therapy. Here, we assessed the effect of once-daily IDegLira compared with BB (once-daily insulin glargine 100 U/mL and insulin aspart ≤4 times/day) across subgroups with varying characteristics. Materials and Methods: DUAL VII trial participants (type 2 diabetes [T2D], HbA1c 53-86 mmol/mol [7.0%-10.0%]) were subgrouped post hoc based on the following baseline characteristics: HbA1c (≤58.5, >58.5 to ≤69.4, and >69.4 mmol/mol; ≤7.5%, >7.5 to ≤8.5%, and >8.5%), body mass index (<30, ≥30 to <35, and ≥35 kg/m2), age (18 to <65 and ≥65 years), duration of diabetes (≥0 to 10 and ≥10 years), total pretrial daily basal insulin dose (20 to <30, ≥30 to <40, and ≥40 to ≤50 U), and fasting plasma glucose (<7.2 mmol/L/<130 mg/dL and ≥7.2 mmol/L/≥130 mg/dL). Results: Compared with BB, and in all subgroups, IDegLira treatment consistently gave similar HbA1c reductions, less severe or blood glucose-confirmed hypoglycemia, lower end-of-trial (EOT) total daily insulin dose, and weight loss. In all subgroups, mean EOT HbA1c was ≤53 mmol/mol (≤7.0%). The greatest HbA1c reduction occurred in the highest baseline HbA1c subgroup. Overall, mean EOT daily insulin dose was 0.43 to 0.52 U/kg with IDegLira and 0.74 to 1.07 U/kg with BB. More participants achieved the triple composite endpoint (HbA1c <53 mmol/mol [<7.0%] without weight gain or hypoglycemia) with IDegLira vs BB across the baseline HbA1c subgroups (≤58.5 mmol/mol [44.6% vs 7.0%], >58.5 to ≤69.4 mmol/mol [41.1% vs 8.3%], and >69.4 mmol/mol [23.8% vs 3.4%]). Conclusion: These results support initiating IDegLira in patients with varying baseline characteristics and uncontrolled T2D on basal insulin. ClinicalTrials.gov registration: NCT02420262 © 2020 Diabetes Technology Society.
Συγγραφείς:
Billings, L.K.
Agner, B.F.R.
Altuntas, Y.
Grøn, R.
Halladin, N.
Klonoff, D.C.
Tentolouris, N.
Jódar, E.
Λέξεις-κλειδιά:
basal insulin; glycosylated hemoglobin; hemoglobin A1c; insulin; insulin aspart; insulin degludec plus liraglutide; insulin glargine; metformin; unclassified drug; antidiabetic agent; glycosylated hemoglobin; insulin degludec; insulin glargine; liraglutide; long acting insulin, adult; aged; antidiabetic activity; Article; blood glucose monitoring; body mass; body weight gain; bolus injection; confidence interval; controlled study; disease duration; double blind procedure; fasting; female; glucose blood level; glucose tolerance test; human; hypoglycemia; insulin treatment; major clinical study; male; maximum tolerated dose; non insulin dependent diabetes mellitus; open study; phase 3 clinical trial; randomized controlled trial; drug combination, Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Combinations; Glycated Hemoglobin A; Humans; Hypoglycemic Agents; Insulin Glargine; Insulin, Long-Acting; Liraglutide
