drugset / Trial / NCT06301529
The Efficacy and Tolerability of Canagliflozin in Healthy Individual
Non-randomizedParallel-groupOpen-labelOther
Summary
The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals. The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol.
Timeline
- Start
- 2024-02-12
- Primary completion
- 2024-06-29
- Completion
- 2024-06-29
Publications
- Background Lin HJ, Lee BC, Ho YL, Lin YH, Chen CY, Hsu HC, Lin MS, Chien KL, Chen MF. Postprandial glucose improves the risk prediction of cardiovascular death beyond the metabolic syndrome in the nondiabetic population. Diabetes Care. 2009 Sep;32(9):1721-6. doi: 10.2337/dc08-2337. Epub 2009 Jun 5.
- Background Leiter LA, Yoon KH, Arias P, Langslet G, Xie J, Balis DA, Millington D, Vercruysse F, Canovatchel W, Meininger G. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015 Mar;38(3):355-64. doi: 10.2337/dc13-2762. Epub 2014 Sep 9.
- Background Suh S, Kim JH. Glycemic Variability: How Do We Measure It and Why Is It Important? Diabetes Metab J. 2015 Aug;39(4):273-82. doi: 10.4093/dmj.2015.39.4.273.
- Results Prasanna Kumar KM, Ghosh S, Canovatchel W, Garodia N, Rajashekar S. A review of clinical efficacy and safety of canagliflozin 300 mg in the management of patients with type 2 diabetes mellitus. Indian J Endocrinol Metab. 2017 Jan-Feb;21(1):196-209. doi: 10.4103/2230-8210.196016.
- Results Papanikolaou Y, Palmer H, Binns MA, Jenkins DJ, Greenwood CE. Better cognitive performance following a low-glycaemic-index compared with a high-glycaemic-index carbohydrate meal in adults with type 2 diabetes. Diabetologia. 2006 May;49(5):855-62. doi: 10.1007/s00125-006-0183-x. Epub 2006 Mar 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 100 mg | Oral |
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 150 mg | Oral |
Indications
No indication recorded.