Phase 3
Completed N=469
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
Source: ClinicalTrials.gov NCT01106625 ↗Enrolled (actual)
469
Serious AEs
5.1%
Results posted
May 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.13; -0.85; -1.06 Percent — p=<0.001
Summary
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo 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 26 |
-0.13; -0.85; -1.06 | <0.001 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 |
18; 43.2; 56.6 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
4.11; -18.2; -30.5 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 |
-0.7; -2.1; -2.6 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 |
-2.65; -4.89; -4.27 | 0.077 |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 |
11.6; 5.4; 8.5 | 0.256 |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 |
3.2; 5.7; 6.5 | 0.153 |
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%
- 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, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Data sourced from ClinicalTrials.gov (NCT01106625). 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.