NCT06301529|CompletedPhase 4FDA Drug
Loading search results
Sponsor study identifier
interventional
30
1 country
1
Study Start
February 12, 2024
Actual (reported)Primary Completion
June 29, 2024
Actual (reported)Study Completion
June 29, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2024
Actual (reported)March 4, 2024
Actual (reported)March 8, 2024
Actual (reported)June 29, 2024
Actual (reported)June 29, 2024
Actual (reported)Change in blood glucose values after taking Canagliflozin
The primary endpoint, average glucose, will be assessed by examining blood glucose (mg/dL) area under curve as measured by CGM. Glucose data on days without Canagliflozin treatment will serve as a control.
2- weeks
Number of participants with treatment-related side effects through collected survey responses
2-weeks
Participants assigned to this arm will be taking 100mg daily, up to 7 times, for study duration.
Participants assigned to this arm will be taking 150mg, every other day, up to 4 times, for study duration.
100 mg and 150 mg doses, taken every day and every-other day, respectively.
AgelessRx
Ann Arbor, Michigan, 48104, United States
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.
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.
James P Faber
Institutional Review Board (IRB) of the Institute of Regenerative and Cellular Medicine (IRCM)
Sajad Zalzala, MD
AgelessRx
30 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2024
First Posted
March 8, 2024
Study Start
February 12, 2024
Actual (reported)Canagliflozin-Mealtime Insulin Rescue
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
June 29, 2024
Actual (reported)Study Completion
June 29, 2024
Actual (reported)Last Updated
July 19, 2024
Record last verified: 2024-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: