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Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients

Effect of oral semaglutide on glucose variability and oxidative stress in type 2 diabetes patients

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The mean age, diabetes duration, and HbA1c values of the semaglutide and DPP-4 inhibitor groups were 65.6 +-11.1 and 66.7 +- 9.9 years, 13.7 +- 6.0 and 14.4 +- 8.9 years, and 7.6 %+- 0.4% and 7.6% +- 0.4%, respectively.

Initially, 60 patients were screened, with one declining to participate and one not meeting the inclusion criteria. Of the remaining 58 patients, 30 were randomly assigned to the semaglutide group and 28 to the DPP-4 inhibitor group. Six patients in the semaglutide group were excluded due to gastrointestinal side effects (n = 3), moving house (n = 1), interruption of hospital visits (n = 1), and dementia (n = 1). One patient in the DPP-4 inhibitor group declined to participate. Ultimately, 24 patients in the semaglutide group and 27 in the DPP-4 inhibitor group were included for analysis .

Three participants in the semaglutide group discontinued treatment due to gastrointestinal side effects, while no adverse events were observed in the DPP-4 inhibitor group. There were no instances of severe hypoglycemia in either group throughout the study.

Switching to oral semaglutide therapy for 24 weeks significantly reduced oxidative stress (-43.5 +- 46.1 vs. -5.4 +- 49.9, p = 0.003), glucose variability such as MGL (-14.0 +- 21.4 mg/dL vs. 2.3 +- 18.9 mg/dL, p = 0.006), SD (-4.3 +- 8.2 mg/dL vs. 1.8 +- 7.6 mg/dL, p = 0.007), MAGE (-17.3 +- 4.3 mg/dL vs. 5.6 +- 22.2 mg/dL, p = 0.001), MODD (-3.8 +- 6.3 mg/dL vs. 1.6 +- 7.6 mg/dL, p = 0.008), TAR (-10.5% +- 15.8% vs. 1.4% +- 15.2%, p = 0.009), TIR (10.4% +- 15.4% vs. -1.5% +- 15.1%, p = 0.008), and hemoglobin A1c levels (-0.5% +- 0.5% vs. 0.0% +- 0.5%, p = 0.001) compared to continuous treatment with DPP-4 inhibitors. However, there was no significant difference in DTSQ scores between the two groups.

Switching to oral semaglutide from DPP-4 inhibitors improved oxidative stress and glucose metabolism, including glucose variability, in patients with T2DM. These results suggest that oral semaglutide may be a more effective therapeutic option for managing T2DM by reducing oxidative stress, a key contributor to diabetic complications.

Jan. 01, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1031210620

Ohara Makoto

Showa University Hospital

1-5-8 Hatanodai Shinagawa-ku Tokyo, Japan

s6018@nms.ac.jp

Ohara Makoto

Showa University Hospital

1-5-8 Hatanodai Shinagawa-ku Tokyo, Japan

+81-3-3784-8000

s6018@nms.ac.jp

Complete

Feb. 18, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

a diagnosis of type 2 diabetes mellitus
1) HbA1c 7.0% or more
2) treatment with DPP-4 inhibitors for 12weeks or longer
3) written informed consent
4) 20 years and over

1)the use of steroids or anti-inflammatory drugs,
2)diabetic ketosis and coma within 3 months before the study,
3)severe infection, severe trauma, pre-and post-operation,
4)an estimated glomerular filtration rate are within 30mL/min/1.73m2,
5)malignancy,
6)pregnancy
7)Patients who are judged as inappropriate for inclusion by phsicians
8)Patients using implantable medical devices such as cardiac pacemakers

Both

type 2 diabetes

Continue DPP-4 inhibitors (regular dose) or switch to oral semaglutide.
Participants in the semaglutide group follow an escalation regimen of semaglutide 7mg (maintenance dose reached after 4 weeks of 3 mg semaglutide once daily).

The primary end point was d-ROMs change from baseline after completing 24 weeks of treatment intervention.

1)The change in glucose variability at 24 weeks from baseline
2) Inflammation markers and AGE-related markers
3) Glucose metabolism index, lipid metabolism index, Renal function, liver function
4) Eating Behavior Questionnaire and DTSQ
5) Blood pressure, pulse, weight

+81-3-3784-8129

Dec. 10, 2021

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