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. 2022 Feb;24(2):332-336.
doi: 10.1111/dom.14564. Epub 2021 Oct 17.

Impact of kidney function on the safety and efficacy of insulin degludec versus insulin glargine U300 in people with type 2 diabetes: A post hoc analysis of the CONCLUDE trial

Thomas R Pieber  1 , Harpreet S Bajaj  2 , Simon R Heller  3 , Ting Jia  4 , Kamlesh Khunti  5 , David C Klonoff  6 , Steen Ladelund  4 , Lawrence A Leiter  7 , Lily Wagner  4 , Athena Philis-Tsimikas  8
Affiliations

Impact of kidney function on the safety and efficacy of insulin degludec versus insulin glargine U300 in people with type 2 diabetes: A post hoc analysis of the CONCLUDE trial

Thomas R Pieber et al. Diabetes Obes Metab. 2022 Feb.
No abstract available

Keywords: insulin analogues; insulin therapy; type 2 diabetes.

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Conflict of interest statement

T.R.P. has received research support from Novo Nordisk, AstraZeneca and Sanofi (paid directly to the Medical University of Graz) and personal fees as a consultant from Adocia, Arecor, AstraZeneca, Eli Lilly, Novo Nordisk and Sanofi. T.R.P. is also the Chief Scientific Officer of CBmed (Centre for Biomarker Research in Medicine), a public‐funded biomarker research company. H.S.B. has received speaking honoraria from Eli Lilly and Novo Nordisk, and research funding paid to LMC Healthcare from Amgen, AstraZeneca, Boehringer Ingelheim, Ceapro, Eli Lilly, Gilead, Janssen, Kowa Pharmaceuticals Co. Ltd, Madrigal Pharmaceuticals, Merck, Pfizer, Novo Nordisk, Sanofi, and Tricida. S.R.H. has served on speaker panels for Novo Nordisk, for which he has received remuneration. He has served on advisory panels and as a consultant for Zealand, Novo Nordisk and Eli Lilly, for which his institution has received remuneration. K.K. has received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche and Sanofi, and research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Roche and Sanofi, and also acknowledges support from the National Institute for Health Research Applied Research Collaboration– East Midlands (NIHR ARC – EM), and the National Institute of Health Research (NIHR) Leicester Biomedical Research Centre. D.C.K. is a consultant for Eoflow, Fractyl, Lifecare, Novo Nordisk, Roche, Samsung and Thirdwayv. L.A.L. has received research support from AstraZeneca, Boehringer Ingelheim, Eli Lilly, GSK, Janssen, Lexicon, Novo Nordisk and Sanofi, and has been on advisory panels and provided continuing medical education for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Pfizer, Sanofi and Servier. A.P.T. has served on advisory panels for Eli Lilly and Co., Dexcom, Inc. and Voluntis, provided consultancy services for Novo Nordisk A/S and Sanofi US, and received research support from Merck & Co., Inc., Novo Nordisk A/S, Sanofi US, Eli Lilly and Co., AstraZeneca, Janssen Pharmaceuticals, Inc. and Genentech, Inc. A.P.T. does not receive any direct or indirect payment for these services. S.L., T.J. and L.W. and are full‐time employees of, and hold stock in, Novo Nordisk A/S.

Figures

FIGURE 1
FIGURE 1
Hypoglycaemia endpoints, by baseline estimated glomerular filtration rate (eGFR) subgroup. Overall symptomatic hypoglycaemic events were defined as severe (requiring third‐party assistance) or confirmed blood glucose <3.1 mmol/L [with symptoms]). Nocturnal symptomatic hypoglycaemic events were defined as severe or blood‐glucose confirmed with symptoms, occurring between 00:01 and 05:59 am. The number of hypoglycaemic events was analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic event was considered treatment emergent as offset. The model included treatment, number of oral antidiabetic drugs, region, gender, dosing time and interaction of kidney function group with treatment as fixed factors, and age as a covariate. †Because of a very low number of events, severe hypoglycaemia was analysed using a simplified model. CI, confidence interval; degludec, insulin degludec; glargine U300, insulin glargine 300 units/mL
FIGURE 2
FIGURE 2
Change from baseline to end of treatment (EOT) in glycated haemoglobin (HbA1c), by baseline estimated glomerular filtration rate (eGFR) subgroup. Mean change in HbA1c from baseline to EOT was analysed using a mixed model for repeated measures with an unstructured residual covariance matrix. Treatment, number of oral antidiabetic drugs, region, sex, dosing time, and interaction between treatment and eGFR category were included as fixed factors. Age and baseline HbA1c were included as covariates. The model included the interaction between visit number and all explanatory variables. CI, confidence interval; degludec, insulin degludec 200 units/mL; glargine U300, insulin glargine 300 units/mL; SD, standard deviation
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References

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