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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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The purpose of this study is to investigate the effect of canagliflozin, a medication approved by the FDA for the treatment of type 2 diabetes, on body weight and metabolism in people with type 2 diabetes who are overweight or obese.
Canagliflozin lowers glucose levels in the blood by making the kidneys excrete, rather than absorb, glucose. Canagliflozin is also often associated with weight loss.
The study population will generally be type 2 diabetics, ages 18-75 years old, who are overweight or obese.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canagliflozin | Experimental | Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. |
|
| Placebo | Placebo Comparator | Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canagliflozin | Drug | Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit. | 18 weeks (duration of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery | Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study. | 18 weeks (duration of study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Canagliflozin | Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks. |
| FG001 | Placebo | Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. Placebo: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks. |
| BG001 | Canagliflozin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 4 placebo dropouts, 2 treatment dropouts |
| 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 | Change in Body Weight | Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit. | Posted | Mean | Standard Error | kg | 18 weeks (duration of study) |
|
duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
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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 | Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. Placebo: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | Systematic Assessment | subject with known COPD experienced COPD flare and pneumonia requiring hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Endocrine disorders | Systematic Assessment | blood sugar values < 70 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Dushay | Beth Israel Deaconess Medical Center | 6176671996 | jdushay@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2017 | Jun 21, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2017 | Jun 21, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001835 | Body Weight |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks. |
|
| Change in Body Composition, Measured Using DXA Scanning. |
Body composition will be measured at baseline and at study completion using DXA scanning. |
| 18 weeks (duration of study) |
| Change in Glycemic Control | Hemoglobin A1C will be measured at baseline and at study completion. | 18 weeks (duration of study) |
Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | dropouts | Mean | Standard Deviation | years |
|
| Sex: Female, Male | dropouts | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | dropouts | Count of Participants | Participants |
|
| Race (NIH/OMB) | dropouts | Count of Participants | Participants |
|
| Region of Enrollment | dropouts | Number | participants |
|
|
|
| Secondary | Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery | Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study. | Posted | Mean | Standard Error | kcal | 18 weeks (duration of study) |
|
|
|
| Secondary | Change in Body Composition, Measured Using DXA Scanning. | Body composition will be measured at baseline and at study completion using DXA scanning. | Posted | Mean | Standard Error | % fat | 18 weeks (duration of study) |
|
|
|
| Secondary | Change in Glycemic Control | Hemoglobin A1C will be measured at baseline and at study completion. | Posted | Mean | Standard Error | percent glycated hemoglobin | 18 weeks (duration of study) |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| 5 |
| 12 |
| EG001 | Canagliflozin | Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks. Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks. | 0 | 13 | 1 | 13 | 5 | 13 |
|
| infection | Infections and infestations | Systematic Assessment | subject experienced cellulitis following planned foot surgery |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment | subject with known hepatic cyst had severe abdominal pain requiring hospitalization and drainage |
|
| polyuria | Renal and urinary disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|