Phase 2
Completed N=279
An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Source: ClinicalTrials.gov NCT01340664 ↗Enrolled (actual)
279
Serious AEs
1.4%
Results posted
Sep 2014
Primary outcomePrimary: Change in HbA1c From Baseline to Week 18 — -0.01; -0.45; -0.61 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 monotherapy (ie, 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 18 |
-0.01; -0.45; -0.61 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18 |
8.1; -15.5; -15.9 | <0.001 sig |
| SECONDARY Percent Change in Body Weight From Baseline to Week 18 |
-0.6; -2.8; -3.2 | <0.001 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 18 |
31.5; 47.8; 57.1 | 0.013 sig |
Eligibility Criteria
Inclusion Criteria
- All patients must have a diagnosis of T2DM and be currently treated with metformin
- 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 (NCT01340664). 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.