Phase 3
Completed N=1,284
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)
Source: ClinicalTrials.gov NCT01106677 ↗Enrolled (actual)
1,284
Serious AEs
3.4%
Results posted
Jul 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.17; -0.79; -0.94; -0.82 Percent — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate glycemic (blood sugar) control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.17; -0.79; -0.94; -0.82 | <0.001 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 |
29.8; 45.5; 57.8; 54.5 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
2.47; -27.3; -37.8; -20.2 | <0.001 sig |
| SECONDARY Change in 2-hour Post-prandial Glucose From Baseline to Week 26 |
-9.79; -47.9; -57.1; -49.3 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 |
-1.2; -3.7; -4.2; -1.2 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 |
1.52; -3.84; -5.06; -1.83 | <0.001 sig |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 |
3.2; 1.6; -1.4; 1.0 | 0.702 |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 |
3.7; 10.4; 12.1; 5.0 | <0.001 sig |
| SECONDARY Change in HbA1c From Baseline to Week 52 |
-0.73; -0.88; -0.73 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 |
-26.2; -35.2; -17.7 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 52 |
-3.8; -4.2; -1.3 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 52 |
-3.53; -4.65; -0.66 | <0.001 sig |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 52 |
1.9; 2.7; -0.4 | 0.466 |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 |
11.2; 13.3; 6.0 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of T2DM and be currently treated with metformin IR
- Patients in the study must have a HbA1c between >=7 and <=10.5%
- Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 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 (NCT01106677). 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.