Phase 2 Completed N=376 Randomized Quadruple-blind Treatment

A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes

Obesity

Source: ClinicalTrials.gov NCT00650806 ↗

Enrolled (actual)

376

Serious AEs

0.3%

Results posted

May 2013

Primary outcomePrimary: Percent Change in Body Weight From Baseline to Week 12 — -1.1; -2.0; -2.8; -2.5 Percent change — p=0.031

Summary

The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Body Weight From Baseline to Week 12	-1.1; -2.0; -2.8; -2.5	0.031 sig
SECONDARY Absolute Change in Body Weight From Baseline to Week 12	-1.1; -1.9; -2.8; -2.4	0.045 sig
SECONDARY Change in Body Mass Index (BMI) From Baseline to Week 12	-0.4; -0.7; -1.0; -0.9	0.031 sig
SECONDARY Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12	8.1; 12.6; 18.8; 17.2	0.317
SECONDARY Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12	0.0; 3.2; 2.4; 1.1	0.117
SECONDARY Change in Waist Circumference From Baseline to Week 12	-1.2; -1.4; -2.9; -2.6	0.835
SECONDARY Change in Hip Circumference From Baseline to Week 12	0.1; -2.0; -2.1; -3.0	0.149
SECONDARY Change in Waist/Hip Ratio From Baseline to Week 12	-0.011; 0.003; -0.008; -0.004	0.239

Eligibility Criteria

Inclusion Criteria

BMI >=30 kg/m2 and =27 kg/m2 and 6.78 mmol/L (600 mg/dL) at screening
History of obesity with a known cause (e.g., Cushing's disease)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00650806). 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.