Trial · NCT01106625
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
NCT01106625, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2013-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea). Trials, record NCT01106625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01106625
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
- NCT number
- NCT01106625
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 469 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Canagliflozin, Placebo, Metformin, Sulphonylruea
- First posted
- 2010-04-20
- Last updated
- 2013-06-20
- Results first posted
- 2013-05-29
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 26 | Day 1 (Baseline) and Week 26 | The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. |
| Secondary | Percentage of Patients With HbA1c <7% at Week 26 | Week 26 | The table below shows the percentage of patients with HbA1c\<7% at Week 26 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage. |
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. |
| Secondary | Percent Change in Body Weight From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. |
| Secondary | Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | The table below shows the least-squares (LS) mean change in SBP from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change. |
| Secondary | Percent Change in Triglycerides From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | The table below shows the least-squares (LS) mean percent change in triglycerides from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change. |
| Secondary | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | The table below shows the least-squares (LS) mean percent change in HDL-C from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent 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 26 | Day 1 (Baseline) and Week 26 | 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 26 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 With HbA1c <7% at Week 26 | Week 26 | 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 26 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 | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | 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 26 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. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Body Weight From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | 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 26 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 Systolic Blood Pressure (SBP) From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | 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 26 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. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Triglycerides From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | 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 26 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 | Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 | Day 1 (Baseline) and Week 26 | 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 26 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 |
Source ClinicalTrials.gov
Results by group21
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 26 | Placebo | -0.13 | Standard Error 0.075 | Percent | |
| Change in HbA1c From Baseline to Week 26 | Canagliflozin 100 mg | -0.85 | Standard Error 0.075 | Percent | |
| Change in HbA1c From Baseline to Week 26 | Canagliflozin 300 mg | -1.06 | Standard Error 0.076 | Percent | |
| Percentage of Patients With HbA1c <7% at Week 26 | Placebo | 18 | Percentage of patients | ||
| Percentage of Patients With HbA1c <7% at Week 26 | Canagliflozin 100 mg | 43.2 | Percentage of patients | ||
| Percentage of Patients With HbA1c <7% at Week 26 | Canagliflozin 300 mg | 56.6 | Percentage of patients | ||
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | Placebo | 4.11 | Standard Error 3.629 | mg/dL | |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | Canagliflozin 100 mg | -18.2 | Standard Error 3.629 | mg/dL | |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 | Canagliflozin 300 mg | -30.5 | Standard Error 3.650 | mg/dL | |
| Percent Change in Body Weight From Baseline to Week 26 | Placebo | -0.7 | Standard Error 0.3 | Percent change |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Period: Baseline to Week 26 | STARTED | Placebo | 156 | |
| Core Period: Baseline to Week 26 | STARTED | Canagliflozin 100 mg | 157 | |
| Core Period: Baseline to Week 26 | STARTED | Canagliflozin 300 mg | 156 | |
| Core Period: Baseline to Week 26 | COMPLETED | Placebo | 123 | |
| Core Period: Baseline to Week 26 | COMPLETED | Canagliflozin 100 mg | 129 | |
| Core Period: Baseline to Week 26 | COMPLETED | Canagliflozin 300 mg | 129 | |
| Core Period: Baseline to Week 26 | NOT COMPLETED | Placebo | 33 | |
| Core Period: Baseline to Week 26 | NOT COMPLETED | Canagliflozin 100 mg | 28 | |
| Core Period: Baseline to Week 26 | NOT COMPLETED | Canagliflozin 300 mg | 27 | |
| Extension Period: Week 26 to Week 52 | STARTED | Placebo | 119 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events276
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 | Influenza | Infections and infestations | Placebo: Baseline to Week 26 | 0 | 156 | |
| other | Influenza | Infections and infestations | Canagliflozin 100 mg: Baseline to Week 26 | 0 | 157 | |
| other | Influenza | Infections and infestations | Canagliflozin 300 mg: Baseline to Week 26 | 0 | 156 | |
| other | Influenza | Infections and infestations | Placebo: Baseline to Week 52 | 8 | 156 | |
| other | Influenza | Infections and infestations | Canagliflozin 100 mg: Baseline to Week 52 | 4 | 157 | |
| other | Influenza | Infections and infestations | Canagliflozin 300 mg: Baseline to Week 52 | 8 | 156 | |
| other | Sinusitis | Infections and infestations | Placebo: Baseline to Week 26 | 0 | 156 | |
| other | Sinusitis | Infections and infestations | Canagliflozin 100 mg: Baseline to Week 26 | 0 | 157 | |
| other | Sinusitis | Infections and infestations | Canagliflozin 300 mg: Baseline to Week 26 | 0 | 156 | |
| other | Sinusitis | Infections and infestations | Placebo: Baseline to Week 52 | 3 | 156 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo: Baseline to Week 26 | ||
| Total, all-cause mortality | Canagliflozin 100 mg: Baseline to Week 26 | ||
| Total, all-cause mortality | Canagliflozin 300 mg: Baseline to Week 26 | ||
| Total, all-cause mortality | Placebo: Baseline to Week 52 | ||
| Total, all-cause mortality | Canagliflozin 100 mg: Baseline to Week 52 | ||
| Total, all-cause mortality | Canagliflozin 300 mg: Baseline to Week 52 | ||
| Total, other adverse events | Placebo: Baseline to Week 26 | 31 | 156 |
| Total, other adverse events | Canagliflozin 100 mg: Baseline to Week 26 | 42 | 157 |
| Total, other adverse events | Canagliflozin 300 mg: Baseline to Week 26 | 38 | 156 |
| Total, other adverse events | Placebo: Baseline to Week 52 | 52 | 156 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers17
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.
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