Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02404870|
Recruitment Status : Recruiting
First Posted : April 1, 2015
Last Update Posted : November 28, 2017
- Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase the bone fracture risk in people with diabetes.
- To see if Invokana has negative side effects on bone health.
- Healthy men ages 18 45.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes PTH Vitamin D Fibroblast Growth Factor (FGF23) Phosphate||Drug: Placebo Drug: Canagliflozin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||175 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers|
|Study Start Date :||September 10, 2014|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||May 1, 2019|
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.
Placebo Comparator: 2
- AUC of FGF23 [ Time Frame: First 24-72 hours ]
- FGF23 peack or AUC [ Time Frame: 12 hours ]
- Transtubular reabsorption of phosphate [ Time Frame: Over 24 hrs x 5 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404870
|Contact: Kristina I Rother, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Kristina I Rother, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|