Obesity, Overweight, Type 2 Diabetes
Conditions
Keywords
Canagliflozin, Obesity, Weight Loss, Body Weight, Body Weight Changes, Overweight, Sodium-glucose transporter subtype 2 inhibitor
Brief summary
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.
Interventions
DRUGCanagliflozin
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
DRUGPlacebo
Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
Sponsors
Janssen Scientific Affairs, LLC
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. BMI 25-45 kg/m2 3. Hemoglobin A1C \> 6.5% but \< 9% 4. Normal renal function (GFR \> 60) 5. Age 18-75
Exclusion criteria
1. Type 1 diabetes 2. History of recurrent UTI or mycotic genital infections 3. Treatment with insulin or a GLP1 agent 4. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 18 weeks (duration of study) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery | 18 weeks (duration of study) | 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. |
| Change in Body Composition, Measured Using DXA Scanning. | 18 weeks (duration of study) | Body composition will be measured at baseline and at study completion using DXA scanning. |
| Change in Glycemic Control | 18 weeks (duration of study) | Hemoglobin A1C will be measured at baseline and at study completion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Placebo | Canagliflozin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 13 Participants | 25 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 1.98 | 61.8 years STANDARD_DEVIATION 2.9 | 59.3 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 13 participants | 25 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 5 / 12 | 5 / 13 |
| serious Total, serious adverse events | 2 / 12 | 1 / 13 |
Outcome results
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.
Time frame: 18 weeks (duration of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin | Change in Body Weight | 3.0 kg | Standard Error 0.7 |
| Placebo | Change in Body Weight | 0.3 kg | Standard Error 0.9 |
Secondary
Change in Body Composition, Measured Using DXA Scanning.
Body composition will be measured at baseline and at study completion using DXA scanning.
Time frame: 18 weeks (duration of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin | Change in Body Composition, Measured Using DXA Scanning. | -0.2 % fat | Standard Error 0.4 |
| Placebo | Change in Body Composition, Measured Using DXA Scanning. | -0.4 % fat | Standard Error 0.4 |
Secondary
Change in Glycemic Control
Hemoglobin A1C will be measured at baseline and at study completion.
Time frame: 18 weeks (duration of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin | Change in Glycemic Control | -0.4 percent glycated hemoglobin | Standard Error 0.1 |
| Placebo | Change in Glycemic Control | -0.1 percent glycated hemoglobin | Standard Error 0.2 |
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.
Time frame: 18 weeks (duration of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canagliflozin | Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery | -60.8 kcal | Standard Error 54.4 |
| Placebo | Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery | -68.6 kcal | Standard Error 84.3 |