Trial · NCT01989754
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
NCT01989754, Phase 4, Completed, Janssen Research & Development, LLC; results first posted 2018-12-11
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus. Trials, record NCT01989754. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01989754
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
- NCT number
- NCT01989754
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 5,813 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Diabetes Mellitus, Type 2, Albuminuria
- Interventions
- Placebo, Canagliflozin, 100 mg, Canagliflozin, 300 mg
- First posted
- 2013-11-21
- Last updated
- 2018-12-11
- Other registries' IDs
- eudract:2013-003050-25
- Results first posted
- 2018-12-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression of Albuminuria | Up to 3 years | 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 macroalbuminuria at baseline (ACR\>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event. |
| Secondary | Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure | Approximately 3 years | Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event. |
| Secondary | Cardiovascular (CV) Death | Approximately 3 years | Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression of Albuminuria | Up to 3 years | The intent to treat (ITT) population included all participants who were randomized. Here 'N' signifies number of participants who were evaluable for this endpoint. | Events per 1000 patient-year | NUMBER |
| SECONDARY | Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure | Approximately 3 years | ITT population included all participants who were randomized. | Events per 1000 patient-years | NUMBER |
| SECONDARY | Cardiovascular (CV) Death | Approximately 3 years | ITT population included all participants who were randomized. | Events per 1000 patient-years | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression of Albuminuria | Placebo | 153.01 | Events per 1000 patient-year | ||
| Progression of Albuminuria | Canagliflozin (Experimental) | 99.80 | Events per 1000 patient-year | ||
| Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure | Placebo | 21.91 | Events per 1000 patient-years | ||
| Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure | Canagliflozin (Experimental) | 15.85 | Events per 1000 patient-years | ||
| Cardiovascular (CV) Death | Placebo | 11.60 | Events per 1000 patient-years | ||
| Cardiovascular (CV) Death | Canagliflozin (Experimental) | 10.06 | Events per 1000 patient-years |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo (Placebo) | 2,905 | |
| Overall Study | STARTED | Canagliflozin (Experimental) | 2,907 | |
| Overall Study | Treated | Placebo (Placebo) | 2,903 | |
| Overall Study | Treated | Canagliflozin (Experimental) | 2,904 | |
| Overall Study | COMPLETED | Placebo (Placebo) | 2,866 | |
| Overall Study | COMPLETED | Canagliflozin (Experimental) | 2,872 | |
| Overall Study | NOT COMPLETED | Placebo (Placebo) | 39 | |
| Overall Study | NOT COMPLETED | Canagliflozin (Experimental) | 35 |
Source ClinicalTrials.gov
Adverse events1,294
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Balanoposthitis | Reproductive system and breast disorders | Placebo (Placebo) | 25 | 2,903 | |
| other | Balanoposthitis | Reproductive system and breast disorders | Canagliflozin (Experimental) | 94 | 2,904 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo (Placebo) | 6 | 2,903 | |
| serious | Anaemia | Blood and lymphatic system disorders | Canagliflozin (Experimental) | 10 | 2,904 | |
| serious | Febrile Neutropenia | Blood and lymphatic system disorders | Placebo (Placebo) | 1 | 2,903 | |
| serious | Febrile Neutropenia | Blood and lymphatic system disorders | Canagliflozin (Experimental) | 0 | 2,904 | |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Placebo (Placebo) | 2 | 2,903 | |
| serious | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Canagliflozin (Experimental) | 1 | 2,904 | |
| serious | Polycythaemia | Blood and lymphatic system disorders | Placebo (Placebo) | 0 | 2,903 | |
| serious | Polycythaemia | Blood and lymphatic system disorders | Canagliflozin (Experimental) | 1 | 2,904 |
1 to 10 of 1,294Source ClinicalTrials.gov
See all 1,294 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Placebo) | 71 | 2,903 |
| Total, all-cause mortality | Canagliflozin (Experimental) | 68 | 2,904 |
| Total, other adverse events | Placebo (Placebo) | 25 | 2,903 |
| Total, other adverse events | Canagliflozin (Experimental) | 94 | 2,904 |
| Total, serious adverse events | Placebo (Placebo) | 775 | 2,903 |
| Total, serious adverse events | Canagliflozin (Experimental) | 714 | 2,904 |
Source ClinicalTrials.gov
Papers29
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Canagliflozin (Experimental) vs Placebo (Placebo): deaths from any cause | Trial comparisons |
| Canagliflozin (Experimental) vs Placebo (Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01989754
GET https://conductscience.org/api/trials/v1/NCT01989754/events?page=2