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

NCT00650806 | Completed Phase 2 Results

• 2 other identifiers: CR01457828431754OBE2001
• Study Type: interventional
• Target: 376
• Locations: 2 countries
• Sites: 36

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.

Conditions

Obesity

Keywords

Obesity; Overweight; Weight loss; Anti-Obesity Agents; Human

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline to Week 12

  The table below shows the mean percent change in body weight from Baseline to Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the least-squares mean percent change.

  Day 1 (Baseline) and Week 12

Secondary Outcomes (7)

• Absolute Change in Body Weight From Baseline to Week 12

  Day 1 (Baseline) and Week 12

• Change in Body Mass Index (BMI) From Baseline to Week 12

  Day 1 (Baseline) and Week 12

• Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12

  Day 1 (Baseline) and Week 12

• Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12

  Day 1 (Baseline) and Week 12

• Change in Waist Circumference From Baseline to Week 12

  Day 1 (Baseline) and Week 12

Study Arms (4)

Canagliflozin 50 mg

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Canagliflozin 100 mg

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Canagliflozin 300 mg

EXPERIMENTAL

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

Drug: Canagliflozin (JNJ-28431754)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Canagliflozin (JNJ-28431754) DRUG

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

Canagliflozin 100 mg; Canagliflozin 300 mg; Canagliflozin 50 mg

Placebo DRUG

One matching placebo capsule orally once daily for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (36)

Unknown Facility

Hot Springs, Arkansas, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Destin, Florida, United States

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Jacksonville, Florida, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Stockbridge, Georgia, United States

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Boise, Idaho, United States

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Eagle, Idaho, United States

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Meridian, Idaho, United States

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Evansville, Indiana, United States

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Overland Park, Kansas, United States

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Witchita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Auburn, Maine, United States

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Milford, Massachusetts, United States

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Jackson, Mississippi, United States

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Omaha, Nebraska, United States

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Manilus, New York, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Goose Creek, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Wauwatosa, Wisconsin, United States

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Ponce, Puerto Rico

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MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise
• Organization: Janssen Research & Development, LLC

1 800 526 7736

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 24, 2013
• Results First Posted: May 24, 2013

Record last verified: 2013-04

Locations

PR (1); US (35)