NCT02404870

Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers

Completed Phase 1 Last updated 4 March 2025

What this trial tests

Phase 1 trial testing Placebo in Healthy Volunteers in 67 participants. Completed in 3 September 2019.

Timeline

16 September 2014

Primary endpoint
1 May 2019

3 September 2019

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	67
Start date	16 September 2014
Primary completion	1 May 2019
Estimated completion	3 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Placebo
• Canagliflozin (CANAGLIFLOZIN) — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase the bone fracture risk in people with diabetes.

Objective:

\- To see if Invokana has negative side effects on bone health.

Eligibility:

\- Healthy men ages 18 45.

Design:

* Participants will be screened with a medical history, physical exam, and blood tests. A nutritionist will discuss their dietary history and the study dietary requirements. Participants will get a food diary to record what they eat and drink on 3 separate days.
* Participants will have a DEXA scan x-ray test of bone health. Participants will lie still on a table while a small camera passes over the body.
* Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6 overnights starting on a Sunday.
* Before each stay, participants will:
* Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks. They must eat only the food provided during these times.
* Collect their urine twice.
* During the stays, participants will:
* Be evaluated by a doctor and have blood drawn.
* On each Monday, participants will:
* Skip breakfast
* At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay.
* Drink 6 ounces of water every 2 hours for 4 hours.
* An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2 hours from 8 a.m. until noon.
* Get lunch.
* Have blood testing again at 8pm and midnight.
* Repeat the testing days 2 5.
* Have urine collected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Canagliflozin triggers the FGF23/1,25-dihydroxyvitamin D/PTH axis in healthy volunteers in a randomized crossover study.
   Blau JE, Bauman V, Conway EM, Piaggi P, et al · · 2018 · cited 117× · PMID 29669938 · DOI 10.1172/jci.insight.99123