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OpenTrials
Completed

NCT Number: NCT06301529

The Efficacy and Tolerability of Canagliflozin in Healthy Individual

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.

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Key information

Conditions

Healthy Aging

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AgelessRx

Ann Arbor, Michigan, 48104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Invokana Pill

Drug

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

Other names: Canagliflozin

Primary outcomes

  1. Change in blood glucose values after taking Canagliflozin

    Time frame: 2- weeks

    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.

Secondary outcomes

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

    Time frame: 2-weeks

    The secondary endpoints of safety and tolerability and urinary glucose excretion will also be assessed. Safety and tolerability will be measured by adverse event reporting, blood pressure monitoring, and by comparing treatment tolerability survey results with control tolerability results through subjective surveys. Urinary glucose excretion will be measured by at-home glucose testing strips.

Sponsors and collaborators

Lead sponsor

AgelessRx

Industry

Registry information

Official study title

The Efficacy and Tolerability of Canagliflozin in Healthy Individuals Comparing Dosing Protocols of Canagliflozin for Use as a Gerotherapeutic

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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