Acute Effect of Rebaudioside A on Glucose Excursion During an Oral Glucose Tolerance Test in Type 2 Diabetes Mellitus

Phase 1 Completed 30 enrolled Universitaire Ziekenhuizen KU Leuven

RandomizedCrossoverOpen-labelTreatment

Summary

Investigate the acute effect of the steviol glycoside, rebaudioside A, on the glucose excursion during an oral glucose tolerance test in 30 patients with type 2 diabetes mellitus.

Timeline

Start: 2018-11-09
Primary completion: 2021-04-01
Completion: 2021-04-01

Outcome

Missed primary endpoint

paper Rebaudioside A did not lower the AUCGlucose(0-2h) compared to placebo (- 0.7 (95% CI - 22.3; 20.9) h·mg/dL, P = 0.95). PMID 36057030 ↗

Publications

Simoens C, Philippaert K, Wuyts C, Goscinny S, Van Hoeck E, Van Loco J, Billen J, de Hoon J, Ampe E, Vangoitsenhoven R, Mertens A, Vennekens R, Van der Schueren B. Pharmacokinetics of Oral Rebaudioside A in Patients with Type 2 Diabetes Mellitus and Its Effects on Glucose Homeostasis: A Placebo-Controlled Crossover Trial. Eur J Drug Metab Pharmacokinet. 2022 Nov;47(6):827-839. doi: 10.1007/s13318-022-00792-7. Epub 2022 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rebaudioside A	Unknown	3 g	Oral