The Efficacy and Tolerability of Canagliflozin in Healthy Individual

AgelessRx

Status and phase: Completed; Phase 4

Conditions: Healthy Aging

Treatments: Drug: Invokana Pill

Study type: Interventional

Funder types: Industry

Identifiers

NCT06301529

ALRx008

Details and patient eligibility

About

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.

Full description

This study is designed to mitigate the effects of glucose with intermittent oral Canagliflozin for healthy, non-diabetic volunteers of any sex who enroll in the study. Participants will provide informed consent via AgelessRx electronic medical record. If eligible, prescriptions will be provided online through the AgelessRx website (www.agelessrx.com). Participants will be randomized into two arms: Arm A will take 100 mg of canagliflozin each day for a total of 7 doses, while Arm B will take 150 mg of canagliflozin every other day for a total of 4 doses. Participants in Arm B will also be provided a pill cutter to use throughout the trial on the 300mg tablet.

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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-85
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

1. Diabetes of any type
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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

100mg

Active Comparator group

Description:

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

Treatment:

Drug: Invokana Pill

150mg

Experimental group

Description:

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

Treatment:

Drug: Invokana Pill