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NCT02404870 · ClinicalTrials.gov registry record · Phase 1
Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT02404870: Completed Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02404870 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02404870, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Canagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2014-09-16 |
| Est. Completion | 2019-09-03 |
| Phase | Phase 1 |
What the finished NCT02404870 record still lists
NCT02404870 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02404870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02404870 about?
NCT02404870 is a clinical study titled "Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers". 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 wil...
What is the current status of trial NCT02404870?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2014-09-16. Estimated completion is 2019-09-03.
What interventions are being tested in trial NCT02404870?
The interventions under investigation include: Placebo (DRUG), Canagliflozin (DRUG).
Who is sponsoring clinical trial NCT02404870?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02404870's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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