The Efficacy and Tolerability of Canagliflozin in Healthy Individual
NCT ID: NCT06301529
Last Updated: 2024-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2024-02-12
2024-06-29
Brief Summary
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The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol.
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Detailed Description
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All participants will begin the trial on the day that they apply a continuous glucose monitor (considered Day 0) and will be asked to take daily blood pressure reading. After one week of baseline readings, both arms will start their canagliflozin dosing protocols.
Participants will be asked to complete 7 total surveys to outline side effects and tolerability, one each day starting after their canagliflozin consumption.
Participants will be asked to complete a dietary intake journal through Day 0 -Day 14. Lifesum (https://lifesum.com/) should be used to track Carbohydrate/Protein/Fat consumption. Participants will share their dietary intake journal twice over their participation (Day 7 \& Day 14).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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100mg
Participants assigned to this arm will be taking 100mg daily, up to 7 times, for study duration.
Invokana Pill
100 mg and 150 mg doses, taken every day and every-other day, respectively.
150mg
Participants assigned to this arm will be taking 150mg, every other day, up to 4 times, for study duration.
Invokana Pill
100 mg and 150 mg doses, taken every day and every-other day, respectively.
Interventions
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Invokana Pill
100 mg and 150 mg doses, taken every day and every-other day, respectively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Any sex
3. Any ethnicity
4. Interest in taking Canagliflozin
5. Approved by the AgelessRx Medical team to take Canagliflozin
6. Willing and technically able to use and operate a continuous glucose monitor
7. Own a CGM-compatible phone
8. Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
9. Adequate cognitive function to be able to give informed consent
Exclusion Criteria
2. Taking metformin or any other glucose-lowering medication
3. Other diabetes medication
4. Active malignancy of any kind
5. Clinically relevant renal or kidney disease or dysfunction
6. History of eating disorder
7. Any diuretic
8. Taking any medication, or having any medical condition, that might interfere with the action of canagliflozin or the CGM sensor
18 Years
85 Years
ALL
Yes
Sponsors
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AgelessRx
INDUSTRY
Responsible Party
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Principal Investigators
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James P Faber
Role: STUDY_CHAIR
Institutional Review Board (IRB) of the Institute of Regenerative and Cellular Medicine (IRCM)
Sajad Zalzala, MD
Role: PRINCIPAL_INVESTIGATOR
AgelessRx
Locations
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AgelessRx
Ann Arbor, Michigan, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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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
Other Identifiers
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ALRx008
Identifier Type: -
Identifier Source: org_study_id
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