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Abstract: SA-PO1035

An Exploratory Clinical Trial on the Efficacy and Safety of the GLP-1 Receptor Agonist Dulaglutide in Patients with Type 2 Diabetes Mellitus on Maintenance Hemodialysis

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Ugamura, Daisuke, Applied Molecular Medicine, Niigata, Japan
  • Hosojima, Michihiro, Clinical Nutrition Science, Niigata, Japan
  • Kabasawa, Hideyuki, Clinical Nutrition Science, Niigata, Japan
  • Tanabe, Naohito, Health and Nutrition, University of Niigata Prefecture, Niigata, Japan
  • Yoshizawa, Yuta, Applied Molecular Medicine, Niigata, Japan
  • Kaseda, Ryohei, Clinical Nephrology, Niigata, Japan
  • Kono, Emiko, Nagaoka Chuo General Hospital, Nagaoka, Japan
  • Takeyama, Aya, Niigata Saiseikai Sanjo Hospital, Sanjo, Japan
  • Miura, Takayoshi, Miura Medical Clinic, Shibata, Japan
  • Fujikawa, Hirokazu, Maihira Clinic, Niigata, niigata, Japan
  • Yamazaki, Hajime, Nagaoka Red Cross Hospital, Nagaoka, Japan
  • Sasage, Hiroki, Niigata Saiseikai Sanjo Hospital, Sanjo, Japan
  • Aoike, Ikuo, Koyo Medical Clinic, Niigata, Japan
  • Miura, Yoshiaki, Miura Medical Clinic, Shibata, Japan
  • Suzuki, Yoshiki, Niigata University Health Administration Center, Niigata, Japan
  • Narita, Ichiei, Clinical Nephrology, Niigata, Japan
  • Saito, Akihiko, Applied Molecular Medicine, Niigata, Japan
Background

Dulaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist approved for the treatment of type 2 diabetes mellitus (T2DM). However, the efficacy and safety of dulaglutide remain unclear in insulin-treated patients with T2DM on maintenance hemodialysis (HD).

Methods

Fourteen insulin-treated T2DM patients on maintenance HD were enrolled. Dulaglutide treatment was initiated and the insulin dose was adjusted as needed. Primary outcomes were changes in the mean and standard deviation (SD) of blood glucose (BG) levels evaluated by continuous glucose monitoring (CGM) for 6 days, and glycoalbumin (GA), HbA1c, and mean daily total insulin dose from baseline over 24 weeks. Secondary outcomes were changes in treatment satisfaction levels from baseline, measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and Diabetes Therapy-Related Quality of Life questionnaire (DTR-QOL) scores. Changes in body composition, including body mass index (BMI), fat mass (FM), skeletal muscle mass (SMM), and rate of interdialytic weight gain (IDWG), were also assessed.

Results

Two patients discontinued the study because of severe nausea or protocol deviation. In the full analysis set, the mean GA change was -3.1% (p = 0.008). Although the mean and SD values of BG and HbA1c levels did not change significantly, mean daily total insulin dose decreased significantly by -16.3 U/day (p = 0.001). Moreover, no significant changes were observed in area over the glucose curve <70 mg/dL per 24 h (AOC<70) in CGM. Six cases of gastrointestinal disorders were reported; however, both the DTSQ treatment satisfaction score (p = 0.029) and DTR-QOL total score (p = 0.014) improved significantly. BMI and FM changes were -0.6 kg/m2 (p = 0.001) and -2.6 kg (p = 0.029), respectively. SMM and IDWG did not significantly change.

Conclusion

Dulaglutide may help improve glycemic control, body composition, and QOL without increasing hypoglycemia in insulin-treated patients with T2DM on maintenance HD.