The Efficacy and Tolerability of Canagliflozin in Healthy Individual

March 4, 2024 updated by: AgelessRx

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • AgelessRx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 100mg
Participants assigned to this arm will be taking 100mg daily, up to 7 times, for study duration.
Drug: Invokana Pill
100 mg and 150 mg doses, taken every day and every-other day, respectively.
Other Names:
  • Canagliflozin
Experimental: 150mg
Participants assigned to this arm will be taking 150mg, every other day, up to 4 times, for study duration.
Drug: Invokana Pill
100 mg and 150 mg doses, taken every day and every-other day, respectively.
Other Names:
  • Canagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2- weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AgelessRx

Investigators

  • Principal Investigator: Sajad Zalzala, MD, AgelessRx
  • Study Chair: James P Faber, Institutional Review Board (IRB) of the Institute of Regenerative and Cellular Medicine (IRCM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Estimated)

April 29, 2024

Study Completion (Estimated)

April 29, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALRx008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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