Phase 3
Completed N=675
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
Source: ClinicalTrials.gov NCT01081834 ↗Enrolled (actual)
675
Serious AEs
3.3%
Results posted
Jun 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 (Main Study) — 0.14; -0.77; -1.03 Percent — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 (Main Study) |
0.14; -0.77; -1.03 | <0.001 sig |
| PRIMARY Change in HbA1c From Baseline to Week 26 (High Glycemic Substudy) |
-2.13; -2.56 | — |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 (Main Study) |
20.6; 44.5; 62.4 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (Main Study) |
8.33; -27.2; -35.0 | <0.001 sig |
| SECONDARY Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (Main Study) |
5.19; -42.9; -58.8 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 (Main Study) |
-0.6; -2.8; -3.9 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (Main Study) |
0.38; -3.34; -5.04 | <0.001 sig |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 (Main Study) |
7.8; 2.5; -2.4 | 0.267 |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (Main Study) |
4.4; 11.2; 10.5 | <0.001 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 (High Glycemic Substudy) |
17.4; 11.6 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 (High Glycemic Substudy) |
-81.7; -86.3 | — |
| SECONDARY Change in 2-hour Post-prandial Glucose From Baseline to Week 26 (High Glycemic Substudy) |
-118; -126 | — |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 (High Glycemic Substudy) |
-3.0; -3.8 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 (High Glycemic Substudy) |
-4.47; -4.97 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 (High Glycemic Substudy) |
-0.6; -12.7 | — |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 (High Glycemic Substudy) |
2.4; 10.8 | — |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of T2DM
- Patients in the main study must have a Hemoglobin A1c (HbA1c) between >=7% and 10% and <=12% and a FPG <=350 mg/dL (19.44 mmol/L)
Exclusion Criteria
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Data sourced from ClinicalTrials.gov (NCT01081834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.