Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers
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.
Timeline
- Start
- 2014-09-16
- Primary completion
- 2019-05-01
- Completion
- 2019-09-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CANAGLIFLOZIN ANHYDROUS | Small molecule | 300 mg | Oral |
Indications
No indication recorded.