Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
The prevalence of obesity is increasing worldwide. Obesity and being overweight are major risk factors for chronic cardiovascular disease, type 2 diabetes mellitus, hypertension and stroke, and certai...
Eligibility Criteria
Inclusion
- BMI \>=30 kg/m2 and \<50 kg/m2 or a BMI \>=27 kg/m2 and \<50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia
- Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening
- Serum creatinine \<=1.5 mg/dL for men and \<=1.4 mg/dL for women at screening
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease
- fasting plasma glucose PG \<7.0 mmol/L (126 mg/dL) at screening
Exclusion
- A history of hereditary glucose-galactose malabsorption or primary renal glycosuria
- An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening
- A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia
- Fasting triglyceride level \>6.78 mmol/L (600 mg/dL) at screening
- History of obesity with a known cause (e.g., Cushing's disease)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00650806
Start Date
May 1 2008
End Date
September 1 2008
Last Update
May 24 2013
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Hot Springs, Arkansas, United States
2
Walnut Creek, California, United States
3
Westlake Village, California, United States
4
Destin, Florida, United States