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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT02404870
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo
  • Canagliflozin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 16, 2014
Status verified
Mar 2025
Primary completion
May 1, 2019
Completion
Sep 3, 2019

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Admission 1 or 2
    Canagliflozin
  • Placebo Comparator: Admission 2 or 1
    Placebo

Primary Outcome Measure

AUC of FGF23 [ Time Frame: First 24-72 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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National Institutes of Health Clinical Center· Bethesda, MD

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