Phase 2
Completed N=451
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes
Diabetes Mellitus, Type II · Diabetes Mellitus, Non Insulin Dependent
Source: ClinicalTrials.gov NCT00642278 ↗
Enrolled (actual)
451
Serious AEs
1.3%
Results posted
May 2013
Primary outcomePrimary: Change in HbA1c From Baseline to Week 12 — -0.22; -0.79; -0.76; -0.70 Percent — p=<0.001
Summary
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 12 |
-0.22; -0.79; -0.76; -0.70; -0.92; -0.95 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 12 |
0.2; -0.9; -1.4; -1.5; -1.4; -1.3 | 0.001 sig |
| SECONDARY Percentage of Patients With Symptoms of Hypoglycemia |
2; 0; 2; 6; 0; 3 | — |
| SECONDARY Change in Overnight Urine Glucose/Creatinine Ratio From Baseline to Week 12 |
1.9; 35.4; 51.5; 50.5; 49.4; 61.6 | <0.001 sig |
| SECONDARY Absolute Change in Body Weight From Baseline to Week 12 |
-0.78; -1.96; -2.25; -2.32; -2.88; -2.87 | — |
| SECONDARY Percent Change in Body Weight From Baseline to Week 12 |
-1.1; -2.3; -2.6; -2.7; -3.4; -3.4 | 0.009 sig |
Eligibility Criteria
Inclusion Criteria
- Patients must have a diagnosis of type 2 diabetes mellitus
- Hemoglobin A1c levels >=7% and <=10.5%
- taking a stable daily dose of metformin
- Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
- Stable body weight
- Serum creatinine <=1.5 mg/dL (132.6 umol/L) for men and <=1.4 mg/dL (123.76 umol/L) for women
Exclusion Criteria
- Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
- Known contraindication or suspected hypersensitivity to sitagliptin or metformin
- A history of diabetic ketoacidosis or type 1 diabetes mellitus
- History of pancreas or beta-cell transplantation
- History of active proliferative diabetic retinopathy
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Data sourced from ClinicalTrials.gov (NCT00642278). 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.