TY - JOUR
T1 - Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin
AU - Meneghini, L.
AU - Doshi, A.
AU - Gouet, D.
AU - Vilsbøll, T.
AU - Begtrup, K.
AU - Őrsy, P.
AU - Ranthe, M. F.
AU - Lingvay, I.
N1 - Funding Information:
This study was supported by Novo Nordisk.
Funding Information:
The authors are grateful to the people who participated in this study, to Randi Grøn, Novo Nordisk, for review of and input to the manuscript, and to Kerry Guest and Catherine Jones, Watermeadow Medical, an Ashfield Company, part of UDG Healthcare plc., for writing and editing assistance, supported by Novo Nordisk. Parts of this study were presented as a poster presentation at the American Diabetes Association, 77th Annual Scientific Sessions, 9–13 June 2017, San Diego, CA, USA.
Funding Information:
LM has received consulting fees or honoraria from Novo Nordisk, Sanofi Aventis and Applied Therapeutics. AD has received advisory board fees from Pfizer Inc. DG has received research support from Novo Nordisk, Lilly, Boehringer‐Ingelheim, Medtronic, Johnson & Johnson and Sanofi. TV has received personal fees from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol‐Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novo Nordisk, Sanofi and Sun Pharmaceuticals and grants (to her institution) from Boehringer‐Ingelheim, Eli Lilly and Novo Nordisk. KB and PO are employees of Novo Nordisk. MFR was an employee of and owned stocks in Novo Nordisk at the time of the study. IL has received research funds, consulting fees and other support from Novo Nordisk through a contract with the University of Texas Southwestern Medical Center and has received consulting fees and/or other support from Lilly, Boehringer‐Ingelheim, Sanofi, Astra Zeneca, Mannkind, Valeritas, TARGETPharma and Intarcia.
Publisher Copyright:
© 2019 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK
PY - 2020/2/1
Y1 - 2020/2/1
N2 - Aims: To assess whether people with type 2 diabetes transferring from higher basal insulin doses (> 20 units) to a starting dose of 16 units of insulin degludec/liraglutide (IDegLira) benefit from IDegLira with/without transient loss of glycaemic control. Methods: Post hoc analysis of DUAL V and VII assessed fasting self-measured blood glucose (SMBG) over weeks 1–8, changes in HbA1c, body weight and mean insulin dose over 26 weeks, and percentage of participants achieving HbA1c < 53 mmol/mol (7.0%) by end of trial in participants with type 2 diabetes uncontrolled with basal insulin. IDegLira was compared with continued up-titration of insulin glargine (IGlar U100) in DUAL V, or switching to basal–bolus therapy in DUAL VII (IGlar U100 and insulin aspart), across pre-trial insulin dose groups (20–29, 30–39 and 40–50 units/day). Results: In all subgroups, participants treated with IDegLira experienced significant improvements in HbA1c by end of trial, which were greater than with IGlar U100 up-titration (estimated treatment difference –5.86, –6.59 and –6.91 mmol/mol for pre-trial insulin doses of 20–29, 30–39 and 40–50 units/day, respectively) and similar to basal–bolus therapy (estimated treatment difference –0.16, –1.0 and –0.01 mmol/mol for pre-trial insulin doses of 20–29, 30–39 and 40–50 units/day, respectively). Compared with IGlar U100 and basal–bolus therapy, IDegLira participants experienced weight loss vs. weight gain, lower rates of hypoglycaemia and a lower mean end of trial total daily insulin dose. In both trials, mean fasting SMBG decreased from weeks 1 to 8 across all subgroups, despite a temporary increase in mean fasting SMBG in the 40–50 units pre-trial insulin dose group during week 1 [mean increase (sd) +1.1 (2.0) mmol/l for DUAL V and +1.1 (2.1) mmol/l for DUAL VII], which reverted to baseline by week 4. Conclusions: Regardless of pre-trial insulin dose, IDegLira resulted in improved clinical outcomes, even in participants transferring from 40–50 units of basal insulin, despite a transient (< 4 weeks), clinically non-relevant, elevation in pre-breakfast SMBG. (Clinical Trial Registry Number NCT01952145 and NCT02420262).
AB - Aims: To assess whether people with type 2 diabetes transferring from higher basal insulin doses (> 20 units) to a starting dose of 16 units of insulin degludec/liraglutide (IDegLira) benefit from IDegLira with/without transient loss of glycaemic control. Methods: Post hoc analysis of DUAL V and VII assessed fasting self-measured blood glucose (SMBG) over weeks 1–8, changes in HbA1c, body weight and mean insulin dose over 26 weeks, and percentage of participants achieving HbA1c < 53 mmol/mol (7.0%) by end of trial in participants with type 2 diabetes uncontrolled with basal insulin. IDegLira was compared with continued up-titration of insulin glargine (IGlar U100) in DUAL V, or switching to basal–bolus therapy in DUAL VII (IGlar U100 and insulin aspart), across pre-trial insulin dose groups (20–29, 30–39 and 40–50 units/day). Results: In all subgroups, participants treated with IDegLira experienced significant improvements in HbA1c by end of trial, which were greater than with IGlar U100 up-titration (estimated treatment difference –5.86, –6.59 and –6.91 mmol/mol for pre-trial insulin doses of 20–29, 30–39 and 40–50 units/day, respectively) and similar to basal–bolus therapy (estimated treatment difference –0.16, –1.0 and –0.01 mmol/mol for pre-trial insulin doses of 20–29, 30–39 and 40–50 units/day, respectively). Compared with IGlar U100 and basal–bolus therapy, IDegLira participants experienced weight loss vs. weight gain, lower rates of hypoglycaemia and a lower mean end of trial total daily insulin dose. In both trials, mean fasting SMBG decreased from weeks 1 to 8 across all subgroups, despite a temporary increase in mean fasting SMBG in the 40–50 units pre-trial insulin dose group during week 1 [mean increase (sd) +1.1 (2.0) mmol/l for DUAL V and +1.1 (2.1) mmol/l for DUAL VII], which reverted to baseline by week 4. Conclusions: Regardless of pre-trial insulin dose, IDegLira resulted in improved clinical outcomes, even in participants transferring from 40–50 units of basal insulin, despite a transient (< 4 weeks), clinically non-relevant, elevation in pre-breakfast SMBG. (Clinical Trial Registry Number NCT01952145 and NCT02420262).
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U2 - 10.1111/dme.14178
DO - 10.1111/dme.14178
M3 - Article
C2 - 31705547
AN - SCOPUS:85076396117
SN - 0742-3071
VL - 37
SP - 267
EP - 276
JO - Diabetic Medicine
JF - Diabetic Medicine
IS - 2
ER -