Trial · NCT00968812
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
NCT00968812, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2013-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride. Trials, record NCT00968812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00968812
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
- NCT number
- NCT00968812
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,452 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Glimepiride, Canagliflozin (JNJ-28431754), Metformin
- First posted
- 2009-08-31
- Last updated
- 2017-01-30
- Other registries' IDs
- eudract:2009-009320-36
- Results first posted
- 2013-06-04
- Limitations and caveats
- No notable study limitations were identified by the Sponsor.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HbA1c From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. |
| Secondary | Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the percentage of patients who experienced at least 1 documented hypoglycemic event from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in percentages. |
| Secondary | Percent Change in Body Weight From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 52 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean percent change. |
| Secondary | Change in HbA1c From Baseline to Week 104 | Baseline, Week 104 | The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 104 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus glimepiride) in the LS mean change. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in HbA1c From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values. | Percentage of patients | NUMBER |
| SECONDARY | Percent Change in Body Weight From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 52 values. Measurements taken pre-rescue used as last observation in patients receiving glycemic rescue therapy. Table includes only patients with both baseline and post baseline values. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in HbA1c From Baseline to Week 104 | Baseline, Week 104 | Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). | Percent | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in HbA1c From Baseline to Week 52 | Canagliflozin 100 mg | -0.82 | Standard Error 0.039 | Percent | |
| Change in HbA1c From Baseline to Week 52 | Canagliflozin 300 mg | -0.93 | Standard Error 0.039 | Percent | |
| Change in HbA1c From Baseline to Week 52 | Glimepiride | -0.81 | Standard Error 0.039 | Percent | |
| Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 | Canagliflozin 100 mg | 5.6 | Percentage of patients | ||
| Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 | Canagliflozin 300 mg | 4.9 | Percentage of patients | ||
| Percentage of Patients Experiencing at Least 1 Hypoglycemic Event From Baseline to Week 52 | Glimepiride | 34.2 | Percentage of patients | ||
| Percent Change in Body Weight From Baseline to Week 52 | Canagliflozin 100 mg | -4.2 | Standard Error 0.2 | Percent change | |
| Percent Change in Body Weight From Baseline to Week 52 | Canagliflozin 300 mg | -4.7 | Standard Error 0.2 | Percent change | |
| Percent Change in Body Weight From Baseline to Week 52 | Glimepiride | 1.0 | Standard Error 0.2 | Percent change | |
| Change in HbA1c From Baseline to Week 104 | Canagliflozin 100 mg | -0.65 | Standard Error 0.042 | Percent |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canagliflozin 100 mg: Baseline to Week 104 | 483 | |
| Overall Study | STARTED | Canagliflozin 300 mg: Baseline to Week 104 | 485 | |
| Overall Study | STARTED | Glimepiride: Baseline to Week 104 | 482 | |
| Overall Study | COMPLETED | Canagliflozin 100 mg: Baseline to Week 104 | 343 | |
| Overall Study | COMPLETED | Canagliflozin 300 mg: Baseline to Week 104 | 323 | |
| Overall Study | COMPLETED | Glimepiride: Baseline to Week 104 | 314 | |
| Overall Study | NOT COMPLETED | Canagliflozin 100 mg: Baseline to Week 104 | 140 | |
| Overall Study | NOT COMPLETED | Canagliflozin 300 mg: Baseline to Week 104 | 162 | |
| Overall Study | NOT COMPLETED | Glimepiride: Baseline to Week 104 | 168 |
Source ClinicalTrials.gov
Adverse events1,008
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 | Diarrhoea | Gastrointestinal disorders | Canagliflozin 100 mg: Baseline to Week 52 | 24 | 483 | |
| other | Diarrhoea | Gastrointestinal disorders | Canagliflozin 300 mg: Baseline to Week 52 | 33 | 485 | |
| other | Diarrhoea | Gastrointestinal disorders | Glimepiride: Baseline to Week 52 | 29 | 482 | |
| other | Diarrhoea | Gastrointestinal disorders | Canagliflozin 100 mg: Baseline to Week 104 | 25 | 482 | |
| other | Diarrhoea | Gastrointestinal disorders | Canagliflozin 300 mg: Baseline to Week 104 | 39 | 485 | |
| other | Diarrhoea | Gastrointestinal disorders | Glimepiride: Baseline to Week 104 | 34 | 482 | |
| other | Nausea | Gastrointestinal disorders | Canagliflozin 100 mg: Baseline to Week 52 | 16 | 483 | |
| other | Nausea | Gastrointestinal disorders | Canagliflozin 300 mg: Baseline to Week 52 | 25 | 485 | |
| other | Nausea | Gastrointestinal disorders | Glimepiride: Baseline to Week 52 | 13 | 482 | |
| other | Nausea | Gastrointestinal disorders | Canagliflozin 100 mg: Baseline to Week 104 | 20 | 483 |
1 to 10 of 1,008Source ClinicalTrials.gov
See all 1,008 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canagliflozin 100 mg: Baseline to Week 52 | ||
| Total, all-cause mortality | Canagliflozin 300 mg: Baseline to Week 52 | ||
| Total, all-cause mortality | Glimepiride: Baseline to Week 52 | ||
| Total, all-cause mortality | Canagliflozin 100 mg: Baseline to Week 104 | ||
| Total, all-cause mortality | Canagliflozin 300 mg: Baseline to Week 104 | ||
| Total, all-cause mortality | Glimepiride: Baseline to Week 104 | ||
| Total, other adverse events | Canagliflozin 100 mg: Baseline to Week 52 | 138 | 483 |
| Total, other adverse events | Canagliflozin 300 mg: Baseline to Week 52 | 150 | 485 |
| Total, other adverse events | Glimepiride: Baseline to Week 52 | 175 | 482 |
| Total, other adverse events | Canagliflozin 100 mg: Baseline to Week 104 | 198 | 483 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers13
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT00968812
GET https://conductscience.org/api/trials/v1/NCT00968812/events?page=2