Trial · NCT01137812
The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
NCT01137812, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2013-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial). Trials, record NCT01137812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01137812
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
- NCT number
- NCT01137812
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 756 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Sitagliptin 100 mg, Canagliflozin 300 mg, Metformin, Sulphonylurea
- First posted
- 2010-06-04
- Last updated
- 2015-01-15
- Results first posted
- 2013-05-17
Source ClinicalTrials.gov
Registered outcomes7
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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. |
| Secondary | Percentage of Patients With HbA1c <7% at Week 52 | Week 52 | The table below shows the percentage of patients with HbA1c \<7% at Week 52 in each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the percentage. |
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. |
| 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 analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean percent change. |
| Secondary | Change in Systolic Blood Pressure (SBP) From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. |
| Secondary | Percent Change in Triglycerides From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the mean percent change in triglycerides from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. |
| Secondary | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | The table below shows the mean percent change in HDL-C from Baseline to Week 52 for each treatment group. The statistical analysis shows the treatment difference (ie, between canagliflozin and sitagliptin) in the LS mean change. |
Source ClinicalTrials.gov
Outcomes7
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 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With HbA1c <7% at Week 52 | Week 52 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | Percentage of patients | NUMBER |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Body Weight From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Systolic Blood Pressure (SBP) From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Triglycerides From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 | Day 1 (Baseline) and Week 52 | This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when the Week 52 values were missing. The table includes only patients with both baseline and post baseline values. | Percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
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 300 mg | -1.03 | Standard Error 0.048 | Percent | |
| Change in HbA1c From Baseline to Week 52 | Sitagliptin 100 mg | -0.66 | Standard Error 0.049 | Percent | |
| Percentage of Patients With HbA1c <7% at Week 52 | Canagliflozin 300 mg | 47.6 | Percentage of patients | ||
| Percentage of Patients With HbA1c <7% at Week 52 | Sitagliptin 100 mg | 35.3 | Percentage of patients | ||
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 | Canagliflozin 300 mg | -29.9 | Standard Error 2.201 | mg/dL | |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 | Sitagliptin 100 mg | -5.85 | Standard Error 2.232 | mg/dL | |
| Percent Change in Body Weight From Baseline to Week 52 | Canagliflozin 300 mg | -2.5 | Standard Error 0.2 | Percent change | |
| Percent Change in Body Weight From Baseline to Week 52 | Sitagliptin 100 mg | 0.3 | Standard Error 0.2 | Percent change | |
| Change in Systolic Blood Pressure (SBP) From Baseline to Week 52 | Canagliflozin 300 mg | -5.06 | Standard Error 0.656 | mmHg | |
| Change in Systolic Blood Pressure (SBP) From Baseline to Week 52 | Sitagliptin 100 mg | 0.85 | Standard Error 0.666 | mmHg |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canagliflozin 300 mg | 377 | |
| Overall Study | STARTED | Sitagliptin 100 mg | 378 | |
| Overall Study | COMPLETED | Canagliflozin 300 mg | 254 | |
| Overall Study | COMPLETED | Sitagliptin 100 mg | 210 | |
| Overall Study | NOT COMPLETED | Canagliflozin 300 mg | 123 | |
| Overall Study | NOT COMPLETED | Sitagliptin 100 mg | 168 |
Source ClinicalTrials.gov
Adverse events104
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 300 mg | 17 | 377 | |
| other | Diarrhoea | Gastrointestinal disorders | Sitagliptin 100 mg | 26 | 378 | |
| other | Influenza | Infections and infestations | Canagliflozin 300 mg | 22 | 377 | |
| other | Influenza | Infections and infestations | Sitagliptin 100 mg | 15 | 378 | |
| other | Nasopharyngitis | Infections and infestations | Canagliflozin 300 mg | 33 | 377 | |
| other | Nasopharyngitis | Infections and infestations | Sitagliptin 100 mg | 38 | 378 | |
| other | Upper respiratory tract infection | Infections and infestations | Canagliflozin 300 mg | 33 | 377 | |
| other | Upper respiratory tract infection | Infections and infestations | Sitagliptin 100 mg | 21 | 378 | |
| other | Urinary tract infection | Infections and infestations | Canagliflozin 300 mg | 15 | 377 | |
| other | Urinary tract infection | Infections and infestations | Sitagliptin 100 mg | 19 | 378 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canagliflozin 300 mg | ||
| Total, all-cause mortality | Sitagliptin 100 mg | ||
| Total, other adverse events | Canagliflozin 300 mg | 157 | 377 |
| Total, other adverse events | Sitagliptin 100 mg | 159 | 378 |
| Total, serious adverse events | Canagliflozin 300 mg | 24 | 377 |
| Total, serious adverse events | Sitagliptin 100 mg | 21 | 378 |
Source ClinicalTrials.gov
Papers8
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Canagliflozin 300 mg vs Sitagliptin 100 mg: serious adverse events |
Source 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.
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/NCT01137812
GET https://conductscience.org/api/trials/v1/NCT01137812/events?page=2