Phase 3
Completed N=755
The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
Source: ClinicalTrials.gov NCT01137812 ↗Enrolled (actual)
755
Serious AEs
6.0%
Results posted
May 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 52 — -1.03; -0.66 Percent — p=<0.05
Summary
The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 52 |
-1.03; -0.66 | <0.05 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 52 |
47.6; 35.3 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52 |
-29.9; -5.85 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 52 |
-2.5; 0.3 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 52 |
-5.06; 0.85 | <0.001 sig |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 52 |
9.6; 11.9 | 0.554 |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 |
7.6; 0.6 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of T2DM and be currently treated with metformin and sulphonylurea
- Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma glucose (FPG) <300 mg/dL (16.7 mmol/L)
Exclusion Criteria
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- or a severe hypoglycemic episode within 6 months before screening
Data sourced from ClinicalTrials.gov (NCT01137812). 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.