Overview

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

Status:
Completed

Trial end date:
2019-09-03

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

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

Treatments:

Canagliflozin