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

NCT ID: NCT00650806

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-09-30

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 certain types of cancers. JNJ-28431754 is being investigated in this study for its possible effectiveness in promoting weight loss when taken over a 12-week period. The study consists of 3 phases: a pretreatment phase that includes a 7-day screening period and a 4-week run-in period, a 12-week double-blind treatment phase (neither the patient nor the investigator will know which treatment the patient is receiving) with an end-of-treatment visit, and a posttreatment phase. In the pretreatment phase, after giving written informed consent, patients will undergo screening evaluations. Patients who successfully complete the screening period will enter the 4-week run-in period and be given dietary and exercise counseling as standardized non-drug therapy for weight loss. During the 12 weeks of treatment, all patients will continue on the study diet and exercise non-drug therapy and will visit the study site about every 3 weeks to have their weight and the results of other safety and effectiveness tests recorded, and to have blood samples collected to measure the concentration of JNJ-28431754 in their blood. In the posttreatment phase, patients will return to the study site for a follow-up visit 14 days after receiving their last dose of study drug. Patient safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); pregnancy tests; physical examinations; electrocardiograms; vital signs measurements; overnight urine collection to measure albumin excretion; assessment of calcium and phosphate homeostasis (balance), bone formation and reabsorption markers, and hormones regulating calcium and phosphorus homeostasis; and self administered vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis and urinary tract infection. Patients will complete 2 questionnaires to record their reactions to taking the study drug and the effect of body weight on their daily lives. About 100 patients of the approximately 400 who qualify for the study, and who consent to this, will take part in 2 oral glucose tolerance tests (OGTTs). During the OGTTs they will drink a glucose solution and have a series of blood samples collected to measure glucose concentration, collect their urine over a 2 hour period, and (at the second OGTT only) have blood samples collected to measure JNJ 28431754 blood concentrations. The primary clinical theory for this study is that at well-tolerated doses, JNJ-28431754 is superior to placebo as measured by the percent change in body weight from baseline (Day 1 of the double-blind treatment period) through Week 12.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Canagliflozin 50 mg

Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.

Group Type: EXPERIMENTAL

Canagliflozin (JNJ-28431754)

Intervention Type: DRUG

One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

Canagliflozin 100 mg

Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.

Group Type: EXPERIMENTAL

Canagliflozin (JNJ-28431754)

Intervention Type: DRUG

One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

Canagliflozin 300 mg

Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.

Group Type: EXPERIMENTAL

Canagliflozin (JNJ-28431754)

Intervention Type: DRUG

One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

Placebo

Each patient will receive matching placebo once daily for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One matching placebo capsule orally once daily for 12 weeks.

Interventions

Canagliflozin (JNJ-28431754)

One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.

Intervention Type: DRUG

Placebo

One matching placebo capsule orally once daily for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Hot Springs, Arkansas, United States

Walnut Creek, California, United States

Westlake Village, California, United States

Destin, Florida, United States

Jacksonville, Florida, United States

Augusta, Georgia, United States

Decatur, Georgia, United States

Stockbridge, Georgia, United States

Boise, Idaho, United States

Eagle, Idaho, United States

Meridian, Idaho, United States

Evansville, Indiana, United States

Overland Park, Kansas, United States

Witchita, Kansas, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Auburn, Maine, United States

Milford, Massachusetts, United States

Jackson, Mississippi, United States

Omaha, Nebraska, United States

Manilus, New York, United States

Medford, Oregon, United States

Portland, Oregon, United States

Goose Creek, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Knoxville, Tennessee, United States

Nashville, Tennessee, United States

Amarillo, Texas, United States

Dallas, Texas, United States

Odessa, Texas, United States

San Antonio, Texas, United States

West Jordan, Utah, United States

Norfolk, Virginia, United States

Wauwatosa, Wisconsin, United States

Ponce, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

28431754OBE2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR014578

Identifier Type: -

Identifier Source: org_study_id