Phase 3
Completed N=342
The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)
Source: ClinicalTrials.gov NCT01106690 ↗Enrolled (actual)
342
Serious AEs
4.8%
Results posted
May 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.26; -0.89; -1.03 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 receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.26; -0.89; -1.03 | <0.001 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 |
32.5; 46.9; 64.3 | 0.007 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
2.54; -26.8; -33.2 | <0.001 sig |
| SECONDARY Change in Homeostasis Model Assessment (HOMA2-%B) From Baseline to Week 26 |
0.91; 15.19; 18.14 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 26 |
-0.1; -2.8; -3.8 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) From Baseline to Week 26 |
-1.24; -5.30; -4.70 | 0.005 sig |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 26 |
15.2; 3.2; -1.7 | 0.034 sig |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26 |
2.4; 7.2; 8.9 | 0.010 sig |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)
- Patients in the study must have a HbA1c between >=7 and <=10.5% and 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 (NCT01106690). 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.