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 : December 5, 2018
- 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|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 Office of Patient Recruitment (OPR) 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)|