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NCT01989754 · ClinicalTrials.gov registry record · Phase 4
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
A Phase 4 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 5,813
- Enrollment target
NCT01989754: Completed Phase 4 study, sponsored by Janssen Research & Development.
NCT01989754 is a Phase 4 study that has completed, run by Janssen Research & Development. The registered enrollment target is 5,813 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1022% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989754, a Phase 4 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5,813 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.
Primary Outcome
Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio \[UACR\] 30 to 300 milligram per gram \[mg/g\]) or macroalbuminuria (Albumin/creatinine ratio \[ACR\] of greater than \[\>\] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than \[\<\] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (\>=) 30 percent from baseline. Participants with macroalbum
Interventions
- DRUG Placebo
- DRUG Canagliflozin, 300 mg
- DRUG Canagliflozin, 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,813 participants |
| Start Date | 2014-01-16 |
| Est. Completion | 2017-02-23 |
| Phase | Phase 4 |
What the finished NCT01989754 record still lists
NCT01989754 is an interventional study that assigns participants to a tested intervention. Its 5,813 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1022% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01989754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989754 about?
NCT01989754 is a clinical study titled "A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus". The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.
What is the current status of trial NCT01989754?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5,813 participants. The study started on 2014-01-16. Estimated completion is 2017-02-23.
What interventions are being tested in trial NCT01989754?
The interventions under investigation include: Placebo (DRUG), Canagliflozin, 300 mg (DRUG), Canagliflozin, 100 mg (DRUG).
Who is sponsoring clinical trial NCT01989754?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989754's enrollment target sits among peer trials
5,813 15th of 2000 higher than 1,986 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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