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
Number of pages9
JournalDiabetes Research and Clinical Practice
Volume153
DOIs
Publication statusPublished - Jul 2019

Keywords

  • Albuminuria/urine
  • Diabetes Mellitus, Type 2/blood
  • Diabetic Nephropathies/drug therapy
  • Exenatide/pharmacology
  • Female
  • Humans
  • Hypoglycemic Agents/pharmacology
  • Insulin Glargine/pharmacology
  • Kidney Function Tests/methods
  • Male
  • Middle Aged
  • Renoprotection
  • Albuminuria
  • Type 2 diabetes mellitus
  • Exenatide
  • Glomerular filtration rate
  • Insulin glargine
  • GLP-1 receptor agonist
  • Diabetic kidney disease

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