Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial

M. H. A. Muskiet, M. C. Bunck, R. J. Heine, A. Cornér, H. Yki-Järvinen, B. Eliasson, J. A. Joles, M. Diamant, L. Tonneijck, D. H. van Raalte

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Aims: To compare the effects of long-term treatment with the GLP-1RA exenatide twice-daily versus titrated insulin glargine (iGlar)on renal function and albuminuria in type 2 diabetes (T2DM)patients. Methods: We post-hoc evaluated renal outcome-data of 54 overweight T2DM patients (mean ± SD age 60 ± 8 years, HbA1c 7.5 ± 0.9%, eGFR 86 ± 16 mL/min/1.73 m2, median [IQR]urinary albumin-to-creatinine-ratio (UACR)0.75 [0.44–1.29]mg/mmol)randomised to exenatide 10 µg twice-daily or titrated iGlar on-top-of metformin for 52-weeks. Renal efficacy endpoints were change in creatinine clearance (CrCl)and albuminuria (urinary albumin-excretion [UAE]and UACR)based on 24-h urines, collected at baseline and Week-52. eGFR and exploratory endpoints were collected throughout the intervention-period, and after a 4-week wash-out. Results: HbA1c-reductions were similar with exenatide (mean ± SEM −0.80 ± 0.10%)and iGlar (−0.79 ± 0.14%; treatment-difference 0.02%; 95% CI −0.31 to 0.42%). Change from baseline to Week-52 in CrCl, UAE or UACR did not statistically differ; only iGlar reduced albuminuria (P < 0.05; within-group). eGFR decreased from baseline to Week-4 with exenatide (−3.9 ± 2.1 mL/min/1.73 m2; P = 0.069)and iGlar (−2.7 ± 1.2 mL/min/1.73 m2; P = 0.034), without treatment-differences in ensuing trajectory. Exenatide versus iGlar reduced bodyweight (−5.4 kg; 2.9–7.9; P < 0.001), but did not affect blood pressure, lipids or plasma uric acid. Conclusions: Among T2DM patients without overt nephropathy, one-year treatment with exenatide twice-daily does not affect renal function-decline or onset/progression of albuminuria compared to titrated iGlar. Trial registration: ClinicalTrials.gov ID: NCT00097500.
Original languageEnglish
Pages (from-to)14-22
JournalDiabetes Research and Clinical Practice
Volume153
DOIs
Publication statusPublished - 2019

Cite this

@article{f40154547ed643398720a004032daa5d,
title = "Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial",
abstract = "Aims: To compare the effects of long-term treatment with the GLP-1RA exenatide twice-daily versus titrated insulin glargine (iGlar)on renal function and albuminuria in type 2 diabetes (T2DM)patients. Methods: We post-hoc evaluated renal outcome-data of 54 overweight T2DM patients (mean ± SD age 60 ± 8 years, HbA1c 7.5 ± 0.9{\%}, eGFR 86 ± 16 mL/min/1.73 m2, median [IQR]urinary albumin-to-creatinine-ratio (UACR)0.75 [0.44–1.29]mg/mmol)randomised to exenatide 10 µg twice-daily or titrated iGlar on-top-of metformin for 52-weeks. Renal efficacy endpoints were change in creatinine clearance (CrCl)and albuminuria (urinary albumin-excretion [UAE]and UACR)based on 24-h urines, collected at baseline and Week-52. eGFR and exploratory endpoints were collected throughout the intervention-period, and after a 4-week wash-out. Results: HbA1c-reductions were similar with exenatide (mean ± SEM −0.80 ± 0.10{\%})and iGlar (−0.79 ± 0.14{\%}; treatment-difference 0.02{\%}; 95{\%} CI −0.31 to 0.42{\%}). Change from baseline to Week-52 in CrCl, UAE or UACR did not statistically differ; only iGlar reduced albuminuria (P < 0.05; within-group). eGFR decreased from baseline to Week-4 with exenatide (−3.9 ± 2.1 mL/min/1.73 m2; P = 0.069)and iGlar (−2.7 ± 1.2 mL/min/1.73 m2; P = 0.034), without treatment-differences in ensuing trajectory. Exenatide versus iGlar reduced bodyweight (−5.4 kg; 2.9–7.9; P < 0.001), but did not affect blood pressure, lipids or plasma uric acid. Conclusions: Among T2DM patients without overt nephropathy, one-year treatment with exenatide twice-daily does not affect renal function-decline or onset/progression of albuminuria compared to titrated iGlar. Trial registration: ClinicalTrials.gov ID: NCT00097500.",
author = "Muskiet, {M. H. A.} and Bunck, {M. C.} and Heine, {R. J.} and A. Corn{\'e}r and H. Yki-J{\"a}rvinen and B. Eliasson and Joles, {J. A.} and M. Diamant and L. Tonneijck and {van Raalte}, {D. H.}",
year = "2019",
doi = "10.1016/j.diabres.2019.05.001",
language = "English",
volume = "153",
pages = "14--22",
journal = "Diabetes Research and Clinical Practice",
issn = "0168-8227",
publisher = "Elsevier Ireland Ltd",

}

Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial. / Muskiet, M. H. A.; Bunck, M. C.; Heine, R. J.; Cornér, A.; Yki-Järvinen, H.; Eliasson, B.; Joles, J. A.; Diamant, M.; Tonneijck, L.; van Raalte, D. H.

In: Diabetes Research and Clinical Practice, Vol. 153, 2019, p. 14-22.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial

AU - Muskiet, M. H. A.

AU - Bunck, M. C.

AU - Heine, R. J.

AU - Cornér, A.

AU - Yki-Järvinen, H.

AU - Eliasson, B.

AU - Joles, J. A.

AU - Diamant, M.

AU - Tonneijck, L.

AU - van Raalte, D. H.

PY - 2019

Y1 - 2019

N2 - Aims: To compare the effects of long-term treatment with the GLP-1RA exenatide twice-daily versus titrated insulin glargine (iGlar)on renal function and albuminuria in type 2 diabetes (T2DM)patients. Methods: We post-hoc evaluated renal outcome-data of 54 overweight T2DM patients (mean ± SD age 60 ± 8 years, HbA1c 7.5 ± 0.9%, eGFR 86 ± 16 mL/min/1.73 m2, median [IQR]urinary albumin-to-creatinine-ratio (UACR)0.75 [0.44–1.29]mg/mmol)randomised to exenatide 10 µg twice-daily or titrated iGlar on-top-of metformin for 52-weeks. Renal efficacy endpoints were change in creatinine clearance (CrCl)and albuminuria (urinary albumin-excretion [UAE]and UACR)based on 24-h urines, collected at baseline and Week-52. eGFR and exploratory endpoints were collected throughout the intervention-period, and after a 4-week wash-out. Results: HbA1c-reductions were similar with exenatide (mean ± SEM −0.80 ± 0.10%)and iGlar (−0.79 ± 0.14%; treatment-difference 0.02%; 95% CI −0.31 to 0.42%). Change from baseline to Week-52 in CrCl, UAE or UACR did not statistically differ; only iGlar reduced albuminuria (P < 0.05; within-group). eGFR decreased from baseline to Week-4 with exenatide (−3.9 ± 2.1 mL/min/1.73 m2; P = 0.069)and iGlar (−2.7 ± 1.2 mL/min/1.73 m2; P = 0.034), without treatment-differences in ensuing trajectory. Exenatide versus iGlar reduced bodyweight (−5.4 kg; 2.9–7.9; P < 0.001), but did not affect blood pressure, lipids or plasma uric acid. Conclusions: Among T2DM patients without overt nephropathy, one-year treatment with exenatide twice-daily does not affect renal function-decline or onset/progression of albuminuria compared to titrated iGlar. Trial registration: ClinicalTrials.gov ID: NCT00097500.

AB - Aims: To compare the effects of long-term treatment with the GLP-1RA exenatide twice-daily versus titrated insulin glargine (iGlar)on renal function and albuminuria in type 2 diabetes (T2DM)patients. Methods: We post-hoc evaluated renal outcome-data of 54 overweight T2DM patients (mean ± SD age 60 ± 8 years, HbA1c 7.5 ± 0.9%, eGFR 86 ± 16 mL/min/1.73 m2, median [IQR]urinary albumin-to-creatinine-ratio (UACR)0.75 [0.44–1.29]mg/mmol)randomised to exenatide 10 µg twice-daily or titrated iGlar on-top-of metformin for 52-weeks. Renal efficacy endpoints were change in creatinine clearance (CrCl)and albuminuria (urinary albumin-excretion [UAE]and UACR)based on 24-h urines, collected at baseline and Week-52. eGFR and exploratory endpoints were collected throughout the intervention-period, and after a 4-week wash-out. Results: HbA1c-reductions were similar with exenatide (mean ± SEM −0.80 ± 0.10%)and iGlar (−0.79 ± 0.14%; treatment-difference 0.02%; 95% CI −0.31 to 0.42%). Change from baseline to Week-52 in CrCl, UAE or UACR did not statistically differ; only iGlar reduced albuminuria (P < 0.05; within-group). eGFR decreased from baseline to Week-4 with exenatide (−3.9 ± 2.1 mL/min/1.73 m2; P = 0.069)and iGlar (−2.7 ± 1.2 mL/min/1.73 m2; P = 0.034), without treatment-differences in ensuing trajectory. Exenatide versus iGlar reduced bodyweight (−5.4 kg; 2.9–7.9; P < 0.001), but did not affect blood pressure, lipids or plasma uric acid. Conclusions: Among T2DM patients without overt nephropathy, one-year treatment with exenatide twice-daily does not affect renal function-decline or onset/progression of albuminuria compared to titrated iGlar. Trial registration: ClinicalTrials.gov ID: NCT00097500.

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UR - https://www.ncbi.nlm.nih.gov/pubmed/31078666

U2 - 10.1016/j.diabres.2019.05.001

DO - 10.1016/j.diabres.2019.05.001

M3 - Article

VL - 153

SP - 14

EP - 22

JO - Diabetes Research and Clinical Practice

JF - Diabetes Research and Clinical Practice

SN - 0168-8227

ER -