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| ID | Type | Description | Link |
|---|---|---|---|
| 28431754OBE2001 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin 50 mg | Experimental | Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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| Canagliflozin 100 mg | Experimental | Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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| Canagliflozin 300 mg | Experimental | Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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| Placebo | Placebo Comparator | Each patient will receive matching placebo once daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin (JNJ-28431754) | Drug | One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Body Weight From Baseline to Week 12 | The table below shows the mean absolute 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 change. | Day 1 (Baseline) and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hot Springs | Arkansas | United States | ||||
A total of 376 patients were randomly allocated to the 4 treatment arms in the study and comprised the intent-to-treat analysis set which was used for the efficacy analyses. All 376 patients received at least 1 dose of study drug and were included in the safety analysis set.
This study evaluated the efficacy and safety of canagliflozin (JNJ-28431754) in nondiabetic, overweight, and obese patients. The study was conducted between 31 March 2008 and 18 September 2008 and recruited patients from 38 study centers located in the United States and Puerto Rico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Each patient received matching placebo once daily for 12 weeks. |
| FG001 | Canagliflozin 50 mg | Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | One matching placebo capsule orally once daily for 12 weeks. |
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| Change in Body Mass Index (BMI) From Baseline to Week 12 |
The table below shows the mean change in BMI 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 change. |
| Day 1 (Baseline) and Week 12 |
| Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12 | The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo). | Day 1 (Baseline) and Week 12 |
| Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12 | The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo). | Day 1 (Baseline) and Week 12 |
| Change in Waist Circumference From Baseline to Week 12 | The table below shows the mean change in waist circumference 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 change. | Day 1 (Baseline) and Week 12 |
| Change in Hip Circumference From Baseline to Week 12 | The table below shows the mean change in hip circumference 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 change. | Day 1 (Baseline) and Week 12 |
| Change in Waist/Hip Ratio From Baseline to Week 12 | The table below shows the mean change in waist/hip ratio 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 change. | Day 1 (Baseline) and Week 12 |
| 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 |
| FG002 | Canagliflozin 100 mg | Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| FG003 | Canagliflozin 300 mg | Each patient received 300 mg of canaliflozin (JNJ-28431754) once daily for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Each patient received matching placebo once daily for 12 weeks. |
| BG001 | Canagliflozin 50 mg | Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| BG002 | Canagliflozin 100 mg | Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| BG003 | Canagliflozin 300 mg | Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region Enroll | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Mean | Standard Deviation | Percent change | Day 1 (Baseline) and Week 12 |
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| Secondary | Absolute Change in Body Weight From Baseline to Week 12 | The table below shows the mean absolute 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 change. | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Mean | Standard Deviation | kg | Day 1 (Baseline) and Week 12 |
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| Secondary | Change in Body Mass Index (BMI) From Baseline to Week 12 | The table below shows the mean change in BMI 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 change. | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Mean | Standard Deviation | kg/m2 | Day 1 (Baseline) and Week 12 |
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| Secondary | Percentage of Patients Who Lost at Least 5% of Their Initial Body Weight by Week 12 | The table below shows the percentage of patients who lost at least 5% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo). | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Number | Percentage of patients | Day 1 (Baseline) and Week 12 |
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| Secondary | Percentage of Patients Who Lost at Least 10% of Their Initial Body Weight by Week 12 | The table below shows the percentage of patients who lost at least 10% of their initial body weight by Week 12 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo). | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Number | Percentage of patients | Day 1 (Baseline) and Week 12 |
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| Secondary | Change in Waist Circumference From Baseline to Week 12 | The table below shows the mean change in waist circumference 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 change. | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Mean | Standard Deviation | cm | Day 1 (Baseline) and Week 12 |
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| Secondary | Change in Hip Circumference From Baseline to Week 12 | The table below shows the mean change in hip circumference 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 change. | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Mean | Standard Deviation | cm | Day 1 (Baseline) and Week 12 |
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| Secondary | Change in Waist/Hip Ratio From Baseline to Week 12 | The table below shows the mean change in waist/hip ratio 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 change. | This analysis was conducted using the intent-to-treat analysis set, which included all patients who were randomly assigned to a treatment group. The last-observation-carried-forward method was applied when the Week 12 values were missing. The table includes only patients with both baseline and post baseline values. | Posted | Mean | Standard Deviation | ratio | Day 1 (Baseline) and Week 12 |
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Adverse events were reported for the duration of the study; each patient participated in the study for approximately 12 weeks.
The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Each patient received matching placebo once daily for 12 weeks. | 0 | 89 | 28 | 89 | ||
| EG001 | Canagliflozin 50 mg | Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. | 1 | 98 | 41 | 98 | ||
| EG002 | Canagliflozin 100 mg | Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. | 0 | 93 | 30 | 93 | ||
| EG003 | Canagliflozin 300 mg | Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. | 0 | 96 | 31 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MEDDRA11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MEDDRA11.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MEDDRA11.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MEDDRA11.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MEDDRA11.0 | Non-systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MEDDRA11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA11.0 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Franchise Medical Leader, Cardiovascular & Metabolism Franchise | Janssen Research & Development, LLC | 1 800 526 7736 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| UNITED STATES |
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Cofactors were treatment, run-in weight loss stratum, and pooled center. |
| <0.001 |
| Least-Squares Mean Difference |
| -1.6 |
| Standard Error of the Mean |
| 0.4 |
| 2-Sided |
| 95 |
| -2.4 |
| -0.8 |
| No |
| Superiority or Other |
| ANOVA | Cofactors were treatment, run-in weight loss stratum, and pooled center. | <0.001 | Least-Squares Mean Difference | -1.4 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -2.1 | -0.6 | No | Superiority or Other |
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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| Canagliflozin 300 mg |
Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. |
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