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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

Diabetes care, 2018-05, Vol.41 (5), p.1009-1016 [Peer Reviewed Journal]

2018 by the American Diabetes Association. ;Copyright American Diabetes Association May 1, 2018 ;ISSN: 0149-5992 ;EISSN: 1935-5548 ;DOI: 10.2337/dc17-1114 ;PMID: 29483185

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Title:
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
Author: Billings, Liana K ; Doshi, Ankur ; Gouet, Didier ; Oviedo, Alejandra ; Rodbard, Helena W ; Tentolouris, Nikolaos ; Grøn, Randi ; Halladin, Natalie ; Jodar, Esteban
Subjects: Adult ; Aged ; Blood Glucose - drug effects ; Blood Glucose - metabolism ; Body weight ; Body weight loss ; Clinical trials ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - drug therapy ; Drug Combinations ; Drug Therapy, Combination ; Evidence-based medicine ; Female ; Glucose ; Glycated Hemoglobin A - analysis ; Hemoglobin ; Humans ; Hypoglycemia ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Insulin ; Insulin - administration & dosage ; Insulin - adverse effects ; Insulin Aspart - administration & dosage ; Insulin Aspart - adverse effects ; Insulin Glargine - administration & dosage ; Insulin Glargine - adverse effects ; Insulin, Long-Acting - administration & dosage ; Insulin, Long-Acting - adverse effects ; Liraglutide - administration & dosage ; Liraglutide - adverse effects ; Male ; Metformin ; Metformin - administration & dosage ; Metformin - adverse effects ; Middle Aged ; Patients ; Research design ; Safety ; Treatment Outcome
Is Part Of: Diabetes care, 2018-05, Vol.41 (5), p.1009-1016
Description: 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. 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. Glycated hemoglobin (HbA ) 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 ( < 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 HbA <7.0% (53 mmol/mol). Total daily insulin dose was lower with IDegLira (40 units) than basal-bolus (84 units total; 52 units basal). In patients with uncontrolled type 2 diabetes on IGlar U100 and metformin, IDegLira treatment elicited HbA reductions comparable to basal-bolus, with statistically superior lower hypoglycemia rates and weight loss versus weight gain.
Publisher: United States: American Diabetes Association
Language: English
Identifier: ISSN: 0149-5992
EISSN: 1935-5548
DOI: 10.2337/dc17-1114
PMID: 29483185
Source: Geneva Foundation Free Medical Journals at publisher websites
MEDLINE
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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

2018 by the American Diabetes Association. ;Copyright American Diabetes Association May 1, 2018 ;ISSN: 0149-5992 ;EISSN: 1935-5548 ;DOI: 10.2337/dc17-1114 ;PMID: 29483185

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