Phase 3
Completed N=269
An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Source: ClinicalTrials.gov NCT01064414 ↗Enrolled (actual)
269
Serious AEs
18.4%
Results posted
May 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 26 — -0.03; -0.33; -0.44 Percent — p=0.012
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 have reduced kidney function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 26 |
-0.03; -0.33; -0.44 | 0.012 sig |
| SECONDARY Percentage of Patients With HbA1c <7% at Week 26 |
17.2; 27.3; 32.6 | 0.227 |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
0.49; -14.9; -11.7 | 0.021 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with T2DM not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non oral agents)
- Patients with reduced kidney function
Exclusion Criteria
- History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
- Kidney disease that required treatment with immunosuppressive therapy, history of dialysis or kidney transplant, presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory kidney disease
- Receiving anti hypertensive or anti-hyperlipidemic therapy not on a stable regimen
- History of a severe hypoglycemic episode within 6 months before screening
Data sourced from ClinicalTrials.gov (NCT01064414). 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.