Trial Outcomes & Findings for Mechanisms of Weight Loss With SGLT2 Inhibition (NCT NCT02360774)
NCT ID: NCT02360774
Last Updated: 2018-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
18 weeks (duration of study)
Results posted on
2018-08-03
Participant Flow
Participant milestones
| Measure |
Canagliflozin
Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
|
Placebo
Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
4 placebo dropouts, 2 treatment dropouts
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
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.
|
Canagliflozin
n=15 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants • 4 placebo dropouts, 2 treatment dropouts
|
0 Participants
n=13 Participants • 4 placebo dropouts, 2 treatment dropouts
|
0 Participants
n=25 Participants • 4 placebo dropouts, 2 treatment dropouts
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants • 4 placebo dropouts, 2 treatment dropouts
|
13 Participants
n=13 Participants • 4 placebo dropouts, 2 treatment dropouts
|
25 Participants
n=25 Participants • 4 placebo dropouts, 2 treatment dropouts
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants • 4 placebo dropouts, 2 treatment dropouts
|
0 Participants
n=13 Participants • 4 placebo dropouts, 2 treatment dropouts
|
0 Participants
n=25 Participants • 4 placebo dropouts, 2 treatment dropouts
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 1.98 • n=12 Participants • dropouts
|
61.8 years
STANDARD_DEVIATION 2.9 • n=13 Participants • dropouts
|
59.3 years
STANDARD_DEVIATION 9.1 • n=25 Participants • dropouts
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants • dropouts
|
6 Participants
n=13 Participants • dropouts
|
11 Participants
n=25 Participants • dropouts
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants • dropouts
|
7 Participants
n=13 Participants • dropouts
|
14 Participants
n=25 Participants • dropouts
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=12 Participants • dropouts
|
1 Participants
n=13 Participants • dropouts
|
2 Participants
n=25 Participants • dropouts
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=12 Participants • dropouts
|
12 Participants
n=13 Participants • dropouts
|
23 Participants
n=25 Participants • dropouts
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants • dropouts
|
0 Participants
n=13 Participants • dropouts
|
0 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants • dropouts
|
0 Participants
n=13 Participants • dropouts
|
0 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=12 Participants • dropouts
|
0 Participants
n=13 Participants • dropouts
|
0 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants • dropouts
|
0 Participants
n=13 Participants • dropouts
|
0 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=12 Participants • dropouts
|
7 Participants
n=13 Participants • dropouts
|
11 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
White
|
7 Participants
n=12 Participants • dropouts
|
5 Participants
n=13 Participants • dropouts
|
12 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=12 Participants • dropouts
|
1 Participants
n=13 Participants • dropouts
|
2 Participants
n=25 Participants • dropouts
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants • dropouts
|
0 Participants
n=13 Participants • dropouts
|
0 Participants
n=25 Participants • dropouts
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants • dropouts
|
13 participants
n=13 Participants • dropouts
|
25 participants
n=25 Participants • dropouts
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Canagliflozin
n=13 Participants
Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
|
Placebo
n=12 Participants
Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
|
|---|---|---|
|
Change in Body Weight
|
3.0 kg
Standard Error 0.7
|
0.3 kg
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Canagliflozin
n=13 Participants
Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
|
Placebo
n=12 Participants
Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
|
|---|---|---|
|
Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery
|
-60.8 kcal
Standard Error 54.4
|
-68.6 kcal
Standard Error 84.3
|
SECONDARY outcome
Timeframe: 18 weeks (duration of study)Body composition will be measured at baseline and at study completion using DXA scanning.
Outcome measures
| Measure |
Canagliflozin
n=13 Participants
Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
|
Placebo
n=12 Participants
Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
|
|---|---|---|
|
Change in Body Composition, Measured Using DXA Scanning.
|
-0.2 % fat
Standard Error 0.4
|
-0.4 % fat
Standard Error 0.4
|
SECONDARY outcome
Timeframe: 18 weeks (duration of study)Hemoglobin A1C will be measured at baseline and at study completion.
Outcome measures
| Measure |
Canagliflozin
n=13 Participants
Subjects will take one 300mg capsule of canagliflozin once daily for 18 weeks.
|
Placebo
n=12 Participants
Subjects will take one 300mg capsule of identically dispensed placebo by mouth once daily for 18 weeks.
|
|---|---|---|
|
Change in Glycemic Control
|
-0.4 percent glycated hemoglobin
Standard Error 0.1
|
-0.1 percent glycated hemoglobin
Standard Error 0.2
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Canagliflozin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
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.
|
Canagliflozin
n=13 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
pneumonia
|
0.00%
0/12 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
7.7%
1/13 • Number of events 1 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
|
Infections and infestations
infection
|
8.3%
1/12 • Number of events 1 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
0.00%
0/13 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
|
Gastrointestinal disorders
abdominal pain
|
8.3%
1/12 • Number of events 1 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
0.00%
0/13 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
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.
|
Canagliflozin
n=13 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
hypoglycemia
|
16.7%
2/12 • Number of events 2 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
15.4%
2/13 • Number of events 2 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
|
Renal and urinary disorders
polyuria
|
41.7%
5/12 • Number of events 5 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
38.5%
5/13 • Number of events 5 • duration of the study. each participant was enrolled for up to 18 weeks
subjects were asked about AEs at each study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place