Healthy VolunteersPhase 1NCT02404870
Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers
A Phase 1 study testing Canagliflozin in people with Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Canagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2014to 3 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We are targeting healthy men and women greater than or equal to 18 years old, inclusive of all races and ethnicity within a BMI of 20 30 kg/m(2). Specifically, we have defined healthy to mean: normal fasting glucose and hemoglobin A1c less than or equal to 6%, normal Hb, no glucosuria, normal renal function (based on normal serum creatinine + Cystatin C), urine albumin:creatinine ratio, protein:creatinine ratio, and GFR > 80 as calculated by the CKD-Epi equation and normal lab urinalysis.
Who cannot join
- If you have any of the following health issues, you cannot participate in the study:
- Presence of heart disease, untreated high blood pressure (>140/90 mm Hg), orthostatic hypotension or symptomatic hypotension, cancer, diabetes, recurrent symptomatic hypoglycemia and /or history of recurrent genital or urinary tract infection, thyroid disease, or any other condition that affects bone health
- Past history of eating disorder or psychiatric disorders, including severe depression, anxiety, or psychosis or presently on treatment with medications for any of these conditions
- Taking certain medications, especially those that affect bone metabolism (e.g., high dose vitamin D [>1000 units daily] or calcium supplements [>800mg daily], high dose vitamin A [>20,000 units daily], phosphate binding antacids, calcitonin, calcitriol, growth hormone, or any anti-seizure medications for any reason including valproic acid, lamotrigine), certain medications for high blood pressure (diuretics), steroids including inhalers, diet/weight loss medications, or any other medications at the discretion of the principal investigator and/or study team
- Have started, increased or decreased calcium [>400mg daily] or vitamin D [>1000 units daily] supplements within 2 weeks of the study
- Dependence or regular use of alcohol (>2 drinks per day), tobacco (smoking or chewing), amphetamines, cocaine, heroin or marijuana over the past 6 months
Show all 22Show fewer
- Volunteers will be excluded if they have abnormal blood concentrations of
- inorganic phosphate level (less than or equal to 2.5 mg/dl or greater than or equal to 4.8 mg/dl),
- parathyroid hormone (PTH) (less than or equal to 60 pg/ml),
- creatinine (less than or equal to 1.5 mg/dl) or eGFR (< 80 ml/min/1.73sq.m),
- fasting glucose (greater than or equal to 100 mg/dl),
- hemoglobin (less than or equal to 11 g/dl),
- liver function tests (more than twice normal),
- testosterone (less than or equal to 260 ng/dl)
- Participation in a vigorous exercise program (>3h/day of vigorous activity)
- Consume more than 300 mg/day of caffeine (about two to three 8 fluid ounce servings)
- Have strict dietary concerns (e.g., vegan or kosher diet, multiple food allergies)
- Cannot commit to the research experience at the Clinical Research Center as required by the study timeline
- Have previous hypersensitivity reaction to canagliflozin (including but not limited to rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing).
- Positive urine pregnancy test and/or planning to become pregnant during the course of the study.
- You are unwilling to use effective contraceptive methods for duration of study (hormonal or barrier.
- Irregular menstrual cycles
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase the bone fracture risk in people with diabetes.
Read more
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.
Read the detailed description
Background
Canagliflozin is a new oral drug for the treatment of type 2 diabetes mellitus (T2DM), and is one of four recently FDA approved sodium glucose co-transporter 2 (SGLT2) inhibitors, which target renal glucose reabsorption and offer promising improvement in HbA1c. In the approval process, the FDA Advisory Committee reviewed data suggesting that canagliflozin increased the incidence of fractures. In addition, the drug induced changes in phosphate, bone resorption markers, parathyroid hormone (PTH) and vitamin D metabolism which might mediate the adverse changes in bone homeostasis. For a variety of reasons, the data on bone fracture risk are relatively limited. First, the drug s development program was focused primarily on demonstrating efficacy, and bone fractures were only one of many safety end-points which were monitored. Second, only a minority of patients (approximately 1%) experienced bone fractures in the course of the development program. Finally, there appears to be a lag time prior to the time increased bone resorption translates into a significant increase in the rate of bone fractures. We hypothesize that this class of drugs causes a cascade of hormonal changes induced by increased phosphorus reabsorption that leads to significant changes in fibroblast growth factor 23 (FGF23), PTH, and vitamin D metabolism which ultimately increase fracture risk.
Aim
The primary endpoint is to determine the effects of canagliflozin on bone health by evaluating changes in the area under the curve (AUC) of FGF23 during the first 24-72 hours. Secondary endpoints include the evaluation of canagliflozin on other biochemical parameters in the early phase (1 week) of drug administration during which we hypothesize a new steady state will be reached related to bone metabolism including PTH, 1,25 vitamin D, tubular reabsorption of phosphate (TRP), and carboxy-terminal telopeptide (CTX).
Methods
A randomized, blinded, placebo-controlled cross-over pilot study of healthy volunteers age 18 years and older with a BMI of 20 - 30 kg/m2.
Patients will be randomized to canagliflozin (300mg once daily) or placebo for 5 days and will be studied as inpatients (NIH Clinical Center metabolic unit). Serial blood and urine testing for 4 hours after daily drug administration and at 12 and 24 hours thereafter will be used to assess changes in the pre-specified endpoints. Each subject will be provided a diet containing fixed contents of phosphate, sodium, and calcium throughout the study, beginning 7 days prior to the administration of drug (or placebo).
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, Canagliflozin
- Keywords
- Diabetes, Phosphate, Fibroblast Growth Factor 23 (FGF23), Vitamin D, PTH
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
CanagliflozinDrug
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 group | Role | What they receive |
|---|---|---|
| Admission 1 or 2 | Experimental | Canagliflozin Receives: Drug: Canagliflozin |
| Admission 2 or 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of FGF23
In this study, our primary endpoint is the area under the curve (AUC) for FGF23 for the 24-72 hours from the first day of administration of canagliflozin. The null hypothesis is that there will be no change in the mean 24-72 hours AUC of FGF23 after the treatment compared with the mean baseline value. We acknowledge that the magnitude and time course of changes (if any) in FGF23 are totally unknown.
Measured: First 24-72 hours
Secondary outcomes (4)
FGF23 peack or AUC
We have chosen 24-72 hour AUC as our best predictionbased on limited previous data on this subject. Therefore, we will include other measurements of FGF23, namely the 12 hr peak and 12 hour AUC for FGF23 to analyze possible changes that occur prior to 24 hours.
Measured: 12 hours
Transtubular reabsorption of phosphate
Renal phosphate transport is a complex interplay between freely filtered phosphate by the glomerulus, reabsorption of phosphate by brush border transporters in the proximal renal tubule, serum phosphate levels and hormonal regulation.
Measured: 12 hours
PTH
We aim to explore if the postulated decreased 1,25 vitamin D leads to a secondary hyperparathyroidism leading to detrimental effects on bone. We hope to define this relationship further by investigating the timing and magnitude of changes in PTH over this short term study. The previous study by Rosenstock et al. 43 may have demonstrated initial increased in PTH that returned to a new baseline (data not available), but it should be noted that (1) the analysis presented is mean data and therefore some individuals likely have higher than average numbers, and (2) small changes in baseline PTH can have important changes in bone homeostasis over time.
Measured: 12 hours
1, 25 vitamin D
In vivo and in vitro studies have demonstrated FGF23 is a potent regulator of 1 - hydroxylase causing rapid reductions in 1,25 vitamin D 66,74,75. Shimada et al. 66 demonstrated in rats that a single injection of FGF23 caused a rapid decrease in 1,25 vitamin D levels by 3 hours, prior to any changes in phosphate (9 hours) or PTH (no change). Therefore, we intend to define the extend and time course of change in 1,25 vitamin D in humans by SGLT2 inhibition.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start16 Sep 2014
- Primary completion1 May 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kelly B Roszko, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404870
- Sponsor's protocol ID
- 140195
- Other IDs
- 14-DK-0195
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2015
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Blau JE, Bauman V, Conway EM, Piaggi P, Walter MF, Wright EC, Bernstein S, Courville AB, Collins MT, Rother KI, Taylor SI. Canagliflozin triggers the FGF23/1,25-dihydroxyvitamin D/PTH axis in healthy volunteers in a randomized crossover study. JCI Insight. 2018 Apr 19;3(8):e99123. doi: 10.1172/jci.insight.99123. eCollection 2018 Apr 19.
PubMed 29669938
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02404870
- Acronym / sponsor ID
- 140195
- Conditions
- Healthy Volunteers
- Keywords
- Diabetes, Phosphate, Fibroblast Growth Factor 23 (FGF23), Vitamin D, PTH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Canagliflozin is a new oral drug for the treatment of type 2 diabetes mellitus (T2DM), and is one of four recently FDA approved sodium glucose co-transporter 2 (SGLT2) inhibitors, which target renal glucose reabsorption and offer promising improvement in HbA1c. In the approval process, the FDA Advisory Committee reviewed data suggesting that canagliflozin increased the incidence of fractures. In addition, the drug induced changes in phosphate, bone resorption markers, parathyroid hormone (PTH) and vitamin D metabolism which might mediate the adverse changes in bone homeostasis. For a variety of reasons, the data on bone fracture risk are relatively limited. First, the drug s development program was focused primarily on demonstrating efficacy, and bone fractures were only one of many safety end-points which were monitored. Second, only a minority of patients (approximately 1%) experienced bone fractures in the course of the development program. Finally, there appears to be a lag time prior to the time increased bone resorption translates into a significant increase in the rate of bone fractures. We hypothesize that this class of drugs causes a cascade of hormonal changes induced by increased phosphorus reabsorption that leads to significant changes in fibroblast growth factor 23 (FGF23), PTH, and vitamin D metabolism which ultimately increase fracture risk.
Aim
The primary endpoint is to determine the effects of canagliflozin on bone health by evaluating changes in the area under the curve (AUC) of FGF23 during the first 24-72 hours. Secondary endpoints include the evaluation of canagliflozin on other biochemical parameters in the early phase (1 week) of drug administration during which we hypothesize a new steady state will be reached related to bone metabolism including PTH, 1,25 vitamin D, tubular reabsorption of phosphate (TRP), and carboxy-terminal telopeptide (CTX).
Methods
A randomized, blinded, placebo-controlled cross-over pilot study of healthy volunteers age 18 years and older with a BMI of 20 - 30 kg/m2.
Patients will be randomized to canagliflozin (300mg once daily) or placebo for 5 days and will be studied as inpatients (NIH Clinical Center metabolic unit). Serial blood and urine testing for 4 hours after daily drug administration and at 12 and 24 hours thereafter will be used to assess changes in the pre-specified endpoints. Each subject will be provided a diet containing fixed contents of phosphate, sodium, and calcium throughout the study, beginning 7 days prior to the administration of drug (or placebo).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Admission 1 or 2 | Experimental | Drug: CanagliflozinCanagliflozin |
| Admission 2 or 1 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We are targeting healthy men and women greater than or equal to 18 years old, inclusive of all races and ethnicity within a BMI of 20 30 kg/m(2). Specifically, we have defined healthy to mean: normal fasting glucose and hemoglobin A1c less than or equal to 6%, normal Hb, no glucosuria, normal renal function (based on normal serum creatinine + Cystatin C), urine albumin:creatinine ratio, protein:creatinine ratio, and GFR > 80 as calculated by the CKD-Epi equation and normal lab urinalysis.
Key exclusion criteria (22 listed)
- Presence of heart disease, untreated high blood pressure (>140/90 mm Hg), orthostatic hypotension or symptomatic hypotension, cancer, diabetes, recurrent symptomatic hypoglycemia and /or history of recurrent genital or urinary tract infection, thyroid disease, or any other condition that affects bone health
- Past history of eating disorder or psychiatric disorders, including severe depression, anxiety, or psychosis or presently on treatment with medications for any of these conditions
- Taking certain medications, especially those that affect bone metabolism (e.g., high dose vitamin D [>1000 units daily] or calcium supplements [>800mg daily], high dose vitamin A [>20,000 units daily], phosphate binding antacids, calcitonin, calcitriol, growth hormone, or any anti-seizure medications for any reason including valproic acid, lamotrigine), certain medications for high blood pressure (diuretics), steroids including inhalers, diet/weight loss medications, or any other medications at the discretion of the principal investigator and/or study team
- Have started, increased or decreased calcium [>400mg daily] or vitamin D [>1000 units daily] supplements within 2 weeks of the study
- Dependence or regular use of alcohol (>2 drinks per day), tobacco (smoking or chewing), amphetamines, cocaine, heroin or marijuana over the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | Admission 2 or 1 |
| CanagliflozinCanagliflozin 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. | Drug | Admission 1 or 2 |
Primary outcome
AUC of FGF23
Time frame: First 24-72 hours
In this study, our primary endpoint is the area under the curve (AUC) for FGF23 for the 24-72 hours from the first day of administration of canagliflozin. The null hypothesis is that there will be no change in the mean 24-72 hours AUC of FGF23 after the treatment compared with the mean baseline value. We acknowledge that the magnitude and time course of changes (if any) in FGF23 are totally unknown.
4 secondary outcomes
FGF23 peack or AUC
Time frame: 12 hours
Transtubular reabsorption of phosphate
Time frame: 12 hours
PTH
Time frame: 12 hours
1, 25 vitamin D
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 29669938Blau JE, Bauman V, Conway EM, Piaggi P, Walter MF, Wright EC, Bernstein S, Courville AB, Collins MT, Rother KI, Taylor SI. Canagliflozin triggers the FGF23/1,25-dihydroxyvitamin D/PTH axis in healthy volunteers in a randomized crossover study. JCI Insight. 2018 Apr 19;3(8):e99123. doi: 10.1172/jci.insight.99123. eCollection 2018 Apr 19.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly B Roszko, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Canagliflozin in people with Healthy Volunteers, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of FGF23 (time frame: First 24-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.