Effect of Dapagliflozin on Urine Metabolome in Patients with Type 2 Diabetes

J Clin Endocrinol Metab. 2021 Apr 23;106(5):1269-1283. doi: 10.1210/clinem/dgab086.

Abstract

Context: Inhibitors of sodium-glucose cotransporters-2 have cardio- and renoprotective properties. However, the underlying mechanisms remain indeterminate.

Objective: To evaluate the effect of dapagliflozin on renal metabolism assessed by urine metabolome analysis in patients with type 2 diabetes.

Design: Prospective cohort study.

Setting: Outpatient diabetes clinic of a tertiary academic center.

Patients: Eighty patients with hemoglobin A1c > 7% on metformin monotherapy were prospectively enrolled.

Intervention: Fifty patients were treated with dapagliflozin for 3 months. To exclude that the changes observed in urine metabolome were merely the result of the improvement in glycemia, 30 patients treated with insulin degludec were used for comparison.

Main outcome measure: Changes in urine metabolic profile before and after the administration of dapagliflozin and insulin degludec were assessed by proton-nuclear magnetic resonance spectroscopy.

Results: In multivariate analysis urine metabolome was significantly altered by dapagliflozin (R2X = 0.819, R2Y = 0.627, Q2Y = 0.362, and coefficient of variation analysis of variance, P < 0.001) but not insulin. After dapagliflozin, the urine concentrations of ketone bodies, lactate, branched chain amino acids (P < 0.001), betaine, myo-inositol (P < 0001), and N-methylhydantoin (P < 0.005) were significantly increased. Additionally, the urine levels of alanine, creatine, sarcosine, and citrate were also increased (P < 0001, P <0.0001, and P <0.0005, respectively) whereas anserine decreased (P < 0005).

Conclusions: Dapagliflozin significantly affects urine metabolome in patients with type 2 diabetes in a glucose lowering-independent way. Most of the observed changes can be considered beneficial and may contribute to the renoprotective properties of dapagliflozin.

Trial registration: ClinicalTrials.gov NCT02798757.

Keywords: branched chain amino acids; dapagliflozin; kidney; metabolomics; osmolytes.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Benzhydryl Compounds / administration & dosage
  • Benzhydryl Compounds / pharmacology*
  • Blood Glucose / drug effects
  • Blood Glucose / metabolism
  • Diabetes Mellitus, Type 2 / drug therapy
  • Diabetes Mellitus, Type 2 / metabolism
  • Diabetes Mellitus, Type 2 / urine*
  • Female
  • Glucosides / administration & dosage
  • Glucosides / pharmacology*
  • Glycated Hemoglobin / drug effects
  • Glycated Hemoglobin / metabolism
  • Greece
  • Humans
  • Male
  • Metabolome / drug effects*
  • Metformin / administration & dosage
  • Middle Aged
  • Treatment Outcome
  • Urinalysis

Substances

  • Benzhydryl Compounds
  • Blood Glucose
  • Glucosides
  • Glycated Hemoglobin A
  • dapagliflozin
  • Metformin

Associated data

  • ClinicalTrials.gov/NCT02798757