The Efficacy and Tolerability of Canagliflozin in Healthy Individual

NCT06301529 | Completed Phase 4 FDA Drug

• 1 other identifier: ALRx008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of participants with treatment-related side effects through collected survey responses

  2-weeks

Study Arms (2)

100mg

ACTIVE COMPARATOR

Participants assigned to this arm will be taking 100mg daily, up to 7 times, for study duration.

Drug: Invokana Pill

150mg

EXPERIMENTAL

Participants assigned to this arm will be taking 150mg, every other day, up to 4 times, for study duration.

Drug: Invokana Pill

Interventions

Invokana Pill DRUG

100 mg and 150 mg doses, taken every day and every-other day, respectively.

Also known as: Canagliflozin

100mg; 150mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Any sex
• Any ethnicity
• Interest in taking Canagliflozin
• Approved by the AgelessRx Medical team to take Canagliflozin
• Willing and technically able to use and operate a continuous glucose monitor
• Own a CGM-compatible phone
• Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
• Adequate cognitive function to be able to give informed consent

You may not qualify if:

• Diabetes of any type
• Taking metformin or any other glucose-lowering medication
• Other diabetes medication
• Active malignancy of any kind
• Clinically relevant renal or kidney disease or dysfunction
• History of eating disorder
• Any diuretic
• Taking any medication, or having any medical condition, that might interfere with the action of canagliflozin or the CGM sensor

Sponsors & Collaborators

• AgelessRx: lead

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (5)

• 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.

  PMID: 19502543 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.

  PMID: 25205142 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.

  PMID: 26301188 BACKGROUND

• 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.

  PMID: 28217522 RESULT

• 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.

  PMID: 16508776 RESULT

Related Links

• Gottfried, Sara MD, "8 Reason Why Glucose is Worth Measuring." Metabolic Basics. June 17, 2022
• Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, et al. (2018) Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol 16(7): e2005143
• (2022), Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the

MeSH Terms

Interventions

Canagliflozin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• James P Faber

  Institutional Review Board (IRB) of the Institute of Regenerative and Cellular Medicine (IRCM)

  STUDY CHAIR

• Sajad Zalzala, MD

  AgelessRx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: February 12, 2024
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (1)