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

NCT02404870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-03-04

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Placebo

Placebo

DRUG

Canagliflozin

Canagliflozin is a new oral drug for the treatment of type 2 diabetes mellitus (T2DM), and is one of two recently FDA approved sodium glucose co-transporter 2 (SGLT2) inhibitors, which target renal glucose reabsorption and offer promising improvement in HbA1C.

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Kelly B Roszko, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-16
Primary Completion
2019-05-01
Completion
2019-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404870 on ClinicalTrials.gov