Trial Outcomes & Findings for Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion (NCT NCT02113241)
NCT ID: NCT02113241
Last Updated: 2020-10-28
Results Overview
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
24 participants
Primary outcome timeframe
Week 12
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Dapagliflozin
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
Baseline characteristics by cohort
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=12 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
49.5 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
46.4 years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Body weight (kg)
|
82.7 kilograms
STANDARD_DEVIATION 12.9 • n=93 Participants
|
80.0 kilograms
STANDARD_DEVIATION 11.3 • n=4 Participants
|
81.4 kilograms
STANDARD_DEVIATION 12.0 • n=27 Participants
|
|
Body Mass Index (BMI) (kg/m^2)
|
33.3 kg/m^2
STANDARD_DEVIATION 3.5 • n=93 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 3.1 • n=4 Participants
|
32.5 kg/m^2
STANDARD_DEVIATION 3.4 • n=27 Participants
|
|
Fat mass (kg)
|
33.2 kilograms
STANDARD_DEVIATION 8.5 • n=93 Participants
|
32.6 kilograms
STANDARD_DEVIATION 8.2 • n=4 Participants
|
32.9 kilograms
STANDARD_DEVIATION 8.2 • n=27 Participants
|
|
Waist circumference (WC) (cm)
|
101.5 centimeters
STANDARD_DEVIATION 10.1 • n=93 Participants
|
96.1 centimeters
STANDARD_DEVIATION 7.2 • n=4 Participants
|
98.9 centimeters
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Systolic Blood Pressure (SBP) (mmHg)
|
121 mmHg
STANDARD_DEVIATION 13 • n=93 Participants
|
126 mmHg
STANDARD_DEVIATION 10 • n=4 Participants
|
123.8 mmHg
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Diastolic Blood Pressure (DBP) (mmHg)
|
78 mmHg
STANDARD_DEVIATION 12 • n=93 Participants
|
79 mmHg
STANDARD_DEVIATION 10 • n=4 Participants
|
78.2 mmHg
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Glucose at minute 0 (0') (mmol/L)
|
6.1 mmol/L
STANDARD_DEVIATION 0.5 • n=93 Participants
|
5.8 mmol/L
STANDARD_DEVIATION 0.6 • n=4 Participants
|
6.0 mmol/L
STANDARD_DEVIATION 0.6 • n=27 Participants
|
|
Glucose at minute 30 (30') (mmol/L)
|
10.7 mmol/L
STANDARD_DEVIATION 2.6 • n=93 Participants
|
9.1 mmol/L
STANDARD_DEVIATION 2.1 • n=4 Participants
|
9.9 mmol/L
STANDARD_DEVIATION 2.4 • n=27 Participants
|
|
Glucose at minute 60 (60') (mmol/L)
|
12.0 mmol/L
STANDARD_DEVIATION 3.8 • n=93 Participants
|
10.4 mmol/L
STANDARD_DEVIATION 2.6 • n=4 Participants
|
11.2 mmol/L
STANDARD_DEVIATION 3.3 • n=27 Participants
|
|
Glucose at minute 90 (90') (mmol/L)
|
10.9 mmol/L
STANDARD_DEVIATION 3.1 • n=93 Participants
|
9.1 mmol/L
STANDARD_DEVIATION 2.6 • n=4 Participants
|
10.0 mmol/L
STANDARD_DEVIATION 2.9 • n=27 Participants
|
|
Glucose at minute 120 (120') (mmol/L)
|
8.9 mmol/L
STANDARD_DEVIATION 2.1 • n=93 Participants
|
7.6 mmol/L
STANDARD_DEVIATION 2.2 • n=4 Participants
|
8.3 mmol/L
STANDARD_DEVIATION 2.2 • n=27 Participants
|
|
Total cholesterol (mmol/L)
|
5.4 mmol/L
STANDARD_DEVIATION 0.7 • n=93 Participants
|
4.9 mmol/L
STANDARD_DEVIATION 1.0 • n=4 Participants
|
5.2 mmol/L
STANDARD_DEVIATION 0.9 • n=27 Participants
|
|
Triglycerides (mmol/L)
|
2.7 mmol/L
STANDARD_DEVIATION 1.4 • n=93 Participants
|
2.0 mmol/L
STANDARD_DEVIATION 0.7 • n=4 Participants
|
2.4 mmol/L
STANDARD_DEVIATION 1.2 • n=27 Participants
|
|
HDL-cholesterol (mmol/L)
|
1.2 mmol/L
STANDARD_DEVIATION 0.2 • n=93 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=4 Participants
|
1.2 mmol/L
STANDARD_DEVIATION 0.3 • n=27 Participants
|
|
LDL-cholesterol (mmol/L)
|
2.9 mmol/L
STANDARD_DEVIATION 1.0 • n=93 Participants
|
2.8 mmol/L
STANDARD_DEVIATION 0.9 • n=4 Participants
|
2.9 mmol/L
STANDARD_DEVIATION 1.0 • n=27 Participants
|
|
Area Under the Curve (AUC) glucose (mmol*hr/L)
|
1235 mmol*hr/L
STANDARD_DEVIATION 304 • n=93 Participants
|
1060 mmol*hr/L
STANDARD_DEVIATION 233 • n=4 Participants
|
1148.3 mmol*hr/L
STANDARD_DEVIATION 280 • n=27 Participants
|
|
Area Under the Curve (AUC) insulin (pmol*hr/L)
|
103910 pmol*hr/L
STANDARD_DEVIATION 55167 • n=93 Participants
|
106683 pmol*hr/L
STANDARD_DEVIATION 41787 • n=4 Participants
|
105297 pmol*hr/L
STANDARD_DEVIATION 47884 • n=27 Participants
|
|
Insulinogenic index (total insulin secretion)
|
0.83 index
STANDARD_DEVIATION 0.64 • n=93 Participants
|
0.98 index
STANDARD_DEVIATION 0.46 • n=4 Participants
|
0.91 index
STANDARD_DEVIATION 0.55 • n=27 Participants
|
|
Stumvoll Index (first phase of insulin secretion)
|
1566 index
STANDARD_DEVIATION 1137 • n=93 Participants
|
1675 index
STANDARD_DEVIATION 819 • n=4 Participants
|
1620.8 index
STANDARD_DEVIATION 971 • n=27 Participants
|
|
Matsuda Index (insulin sensitivity)
|
2.0 index
STANDARD_DEVIATION 1.1 • n=93 Participants
|
1.8 index
STANDARD_DEVIATION 0.8 • n=4 Participants
|
1.9 index
STANDARD_DEVIATION 1.0 • n=27 Participants
|
|
Creatinine (mmol/L)
|
0.06 mmol/L
STANDARD_DEVIATION 0.02 • n=93 Participants
|
0.07 mmol/L
STANDARD_DEVIATION 0.02 • n=4 Participants
|
0.07 mmol/L
STANDARD_DEVIATION 0.02 • n=27 Participants
|
|
Uric acid (umol/L)
|
267.7 umol/L
STANDARD_DEVIATION 95.2 • n=93 Participants
|
315.2 umol/L
STANDARD_DEVIATION 101.1 • n=4 Participants
|
291.5 umol/L
STANDARD_DEVIATION 101.1 • n=27 Participants
|
|
Alanine aminotransferase (ALT)
|
50.9 U/L
STANDARD_DEVIATION 31.6 • n=93 Participants
|
37.9 U/L
STANDARD_DEVIATION 17.1 • n=4 Participants
|
44.4 U/L
STANDARD_DEVIATION 25.7 • n=27 Participants
|
|
Aspartate aminotransferase (AST)
|
37.9 U/L
STANDARD_DEVIATION 19.1 • n=93 Participants
|
28.8 U/L
STANDARD_DEVIATION 17.7 • n=4 Participants
|
33.4 U/L
STANDARD_DEVIATION 18.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Waist Circumference at Week 12.
|
97.6 centimeters
Standard Deviation 8.9
|
97.2 centimeters
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Triglycerides Levels at Week 12.
|
1.7 mmol/L
Standard Deviation 0.8
|
1.7 mmol/L
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
High Density Lipoprotein (c-HDL) Levels at Week 12.
|
1.3 mmol/L
Standard Deviation 0.2
|
1.3 mmol/L
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: Week 12Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Glucose Levels at Minute 0 at Week 12.
|
5.7 mmol/L
Standard Deviation 1.1
|
5.8 mmol/L
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Week 12The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Systolic Blood Pressure at Week 12.
|
117 mmHg
Standard Deviation 10
|
121 mmHg
Standard Deviation 13
|
PRIMARY outcome
Timeframe: Week 12The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Diastolic Blood Pressure at Week 12.
|
76 mmHg
Standard Deviation 8
|
79 mmHg
Standard Deviation 10
|
PRIMARY outcome
Timeframe: Week 12The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Insulinogenic Index (Total Insulin Secretion) at Week 12.
|
0.35 index
Standard Deviation 0.11
|
0.99 index
Standard Deviation 0.38
|
PRIMARY outcome
Timeframe: Week 12Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the frst phase of insulin secretion at week 12.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Stumvoll Index (First Phase of Insulin Secretion) at Week 12.
|
1463 index
Standard Deviation 879
|
2198 index
Standard Deviation 996
|
PRIMARY outcome
Timeframe: Week 12Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity at week 12.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Matsuda Index (Total Insulin Sensitivity) at Week 12.
|
2.7 index
Standard Deviation 1.4
|
1.6 index
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 12The weight it's going to be measured at week 12 with a bioimpedance balance.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Body Weight at Week 12.
|
81.2 kilograms
Standard Deviation 12.8
|
79.6 kilograms
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Week 12The Body Mass index it's going to be calculated at week 12 with the Quetelet index.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Body Mass Index at Week 12
|
32.6 kg/m^2
Standard Deviation 3.6
|
32.1 kg/m^2
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Week 12The fat mass is going to be evaluated at week 12 through bioimpedance.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Fat Mass at Week 12.
|
32.7 kilograms
Standard Deviation 9.2
|
34.4 kilograms
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Week 12The total cholesterol will be estimated by standardized techniques at week 12.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Total Cholesterol at Week 12
|
5.2 mmol/L
Standard Deviation 0.7
|
4.9 mmol/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Week 12The c-LDL levels are going to be measured at week 12 with standardized techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Low Density Lipoproteins (c-LDL) at Week 12
|
3.1 mmol/L
Standard Deviation 0.5
|
2.8 mmol/L
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Week 12.The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Alanine Aminotransferase (ALT) at Week 12.
|
32.1 U/L
Standard Deviation 15.9
|
38.1 U/L
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: Week 12The hepatic transaminase AST will be evaluated with standardized methods at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Aspartate Aminotransferase (AST) at Week 12.
|
31.1 U/L
Standard Deviation 14.5
|
29.5 U/L
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Week 12.The creatinine levels are going to be measured at week 12 with standardized techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Creatinine at Week 12.
|
0.07 mmol/L
Standard Deviation 0.01
|
0.05 mmol/L
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Week 12.The uric acid levels are going to be measured at week 12 with standardized techniques.
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Uric Acid at Week 12.
|
243.9 umol/L
Standard Deviation 55.3
|
339.0 umol/L
Standard Deviation 53.5
|
SECONDARY outcome
Timeframe: Week 12The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
AUC of Glucose at Week 12.
|
1153 mmol*hr/L
Standard Deviation 280
|
1129 mmol*hr/L
Standard Deviation 232
|
SECONDARY outcome
Timeframe: Week 12The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
AUC of Insulin at Week 12.
|
45016 pmol*h/L
Standard Deviation 22147
|
119704 pmol*h/L
Standard Deviation 46872
|
SECONDARY outcome
Timeframe: Week 12The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Glucose at Minute 30 at Week 12.
|
10.5 mmol/L
Standard Deviation 2.0
|
10.0 mmol/L
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Week 12The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Glucose at Minute 60 at Week 12.
|
11.1 mmol/L
Standard Deviation 3.1
|
11.4 mmol/L
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Week 12The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Glucose at Minute 90 at Week 12.
|
9.8 mmol/L
Standard Deviation 3.5
|
9.9 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Week 12The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve
Outcome measures
| Measure |
Dapagliflozin
n=12 Participants
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=11 Participants
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Glucose at Minute 120 at Week 12.
|
8.5 mmol/L
Standard Deviation 2.1
|
8.8 mmol/L
Standard Deviation 2.2
|
Adverse Events
Dapagliflozin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dapagliflozin
n=12 participants at risk
Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
|
Placebo
n=12 participants at risk
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
|
|---|---|---|
|
Infections and infestations
Urinary infection
|
8.3%
1/12 • Number of events 1 • Adverse events were collected during the 12 weeks of the study
|
0.00%
0/12 • Adverse events were collected during the 12 weeks of the study
|
Additional Information
DR. MANUEL GONZALEZ ORTIZ
INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
Phone: +52 3310585200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place