Trial Outcomes & Findings for Effectiveness of Dapagliflozin for Weight Loss (NCT NCT03968224)
NCT ID: NCT03968224
Last Updated: 2025-10-15
Results Overview
Change in weight using (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
160 participants
Primary outcome timeframe
12 months
Results posted on
2025-10-15
Participant Flow
Patients with grade III obesity undergoing a bariatric surgery protocol were recluded at Hospital de Especialidades Centro Medico Nacional Siglo XXI, IMSS between 2018 and 2024. The first participant was enrolled on August 4th 2018 and the last participant was enrolled in July 31st 2023.
Of 160 enrolled participants, 109 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Metformin/Dapagliflozin
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
|
Metformin
Metformin 1,700 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
55
|
|
Overall Study
COMPLETED
|
43
|
37
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
Reasons for withdrawal
| Measure |
Metformin/Dapagliflozin
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
|
Metformin
Metformin 1,700 mg/day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
18
|
Baseline Characteristics
Effectiveness of Dapagliflozin for Weight Loss
Baseline characteristics by cohort
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Years
|
46 years
STANDARD_DEVIATION 8 • n=5 Participants
|
42 years
STANDARD_DEVIATION 9 • n=7 Participants
|
44 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
54 participants
n=5 Participants
|
55 participants
n=7 Participants
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsChange in weight using (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Weight
Initial weight
|
121.5 kg
Standard Deviation 21.1
|
125.9 kg
Standard Deviation 23.9
|
|
Change in Weight
Weight (1 month)
|
118 kg
Standard Deviation 20.8
|
123.7 kg
Standard Deviation 21.8
|
|
Change in Weight
Weight (3 months)
|
116.3 kg
Standard Deviation 20.11
|
120 kg
Standard Deviation 20.58
|
|
Change in Weight
Weight (6 months)
|
114.4 kg
Standard Deviation 17.8
|
119.9 kg
Standard Deviation 22.4
|
|
Change in Weight
Weight (9 months)
|
115.4 kg
Standard Deviation 17.9
|
118.4 kg
Standard Deviation 21.4
|
|
Change in Weight
Final weight (12 months)
|
116 kg
Standard Deviation 19
|
115 kg
Standard Deviation 20.18
|
SECONDARY outcome
Timeframe: 12 monthsChange in blood pressure using (dapaglifozin/metformin) vs. metformin at three, six, nine and twelve months.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Blood Pressure
Initial Systolic blood pressure
|
115 mmHg
Standard Deviation 14
|
120 mmHg
Standard Deviation 13
|
|
Change in Blood Pressure
Initial Diastolic blood pressure
|
80 mmHg
Standard Deviation 10
|
81 mmHg
Standard Deviation 8
|
|
Change in Blood Pressure
Systolic blood pressure (3 months)
|
113 mmHg
Standard Deviation 14
|
199 mmHg
Standard Deviation 11
|
|
Change in Blood Pressure
Diastolic blood pressure (3 months)
|
77 mmHg
Standard Deviation 9
|
78 mmHg
Standard Deviation 13
|
|
Change in Blood Pressure
Systolic blood pressure (6 months)
|
113 mmHg
Standard Deviation 11
|
118 mmHg
Standard Deviation 15
|
|
Change in Blood Pressure
Diastolic blood pressure (6 months)
|
77 mmHg
Standard Deviation 8
|
78 mmHg
Standard Deviation 9
|
|
Change in Blood Pressure
Systolic blood pressure (9 months)
|
114 mmHg
Standard Deviation 14
|
116 mmHg
Standard Deviation 13
|
|
Change in Blood Pressure
Diastolic blood pressure (9 months)
|
77 mmHg
Standard Deviation 11
|
74 mmHg
Standard Deviation 8
|
|
Change in Blood Pressure
Final Systolic blood pressure (12 months)
|
122 mmHg
Standard Deviation 14
|
120 mmHg
Standard Deviation 20
|
|
Change in Blood Pressure
Final Diastolic blood pressure (12 months)
|
79 mmHg
Standard Deviation 8
|
76 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 12 monthsChange in waist circumference in (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Waist Circumference
Initial waist circumference
|
130 cm
Standard Deviation 13
|
131 cm
Standard Deviation 14
|
|
Change in Waist Circumference
Waist circumference (1 month)
|
123 cm
Standard Deviation 22
|
129 cm
Standard Deviation 11
|
|
Change in Waist Circumference
Waist circumference (3 months)
|
124 cm
Standard Deviation 14
|
126 cm
Standard Deviation 13
|
|
Change in Waist Circumference
Waist circumference (6 months)
|
124 cm
Standard Deviation 12
|
124 cm
Standard Deviation 13
|
|
Change in Waist Circumference
Waist circumference (9 months)
|
124 cm
Standard Deviation 11
|
124 cm
Standard Deviation 14
|
|
Change in Waist Circumference
Final waist circumference ( 12 months)
|
125 cm
Standard Deviation 11
|
123 cm
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 12 monthsChange in lipid levels using (dapaglifozin/metformin) vs. metformin in three, six, nine and twelve months.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Lipid Levels
Initial c-HDL
|
41 mg/dl
Standard Deviation 10
|
39 mg/dl
Standard Deviation 8
|
|
Change in Lipid Levels
Initial c-LDL
|
91 mg/dl
Standard Deviation 27
|
93 mg/dl
Standard Deviation 29
|
|
Change in Lipid Levels
Initial CT
|
167 mg/dl
Standard Deviation 29
|
162 mg/dl
Standard Deviation 33
|
|
Change in Lipid Levels
Initial TAG
|
154 mg/dl
Standard Deviation 122
|
138 mg/dl
Standard Deviation 107
|
|
Change in Lipid Levels
c-HDL (3 months)
|
42 mg/dl
Standard Deviation 9
|
41 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
c-LDL (3 months)
|
89 mg/dl
Standard Deviation 27
|
41 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
CT (3 months)
|
161 mg/dl
Standard Deviation 39
|
164 mg/dl
Standard Deviation 32
|
|
Change in Lipid Levels
TAG (3 months)
|
158 mg/dl
Standard Deviation 117
|
154 mg/dl
Standard Deviation 111
|
|
Change in Lipid Levels
c-HDL (6 months)
|
42 mg/dl
Standard Deviation 10
|
42 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
c-LDL (6 months)
|
93 mg/dl
Standard Deviation 27
|
42 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
CT (6 months)
|
167 mg/dl
Standard Deviation 30
|
173 mg/dl
Standard Deviation 31
|
|
Change in Lipid Levels
TAG (6 months)
|
146 mg/dl
Standard Deviation 116
|
142 mg/dl
Standard Deviation 131
|
|
Change in Lipid Levels
c-HDL (9 months)
|
49 mg/dl
Standard Deviation 19
|
43 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
c-LDL (9 months)
|
98 mg/dl
Standard Deviation 36
|
43 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
CT (9 months)
|
174 mg/dl
Standard Deviation 41
|
168 mg/dl
Standard Deviation 40
|
|
Change in Lipid Levels
TAG (9 months)
|
145 mg/dl
Standard Deviation 124
|
136 mg/dl
Standard Deviation 114
|
|
Change in Lipid Levels
Final c-HDL (12 months)
|
42 mg/dl
Standard Deviation 10
|
43 mg/dl
Standard Deviation 9
|
|
Change in Lipid Levels
Final c-LDL (12 months)
|
96 mg/dl
Standard Deviation 29
|
94 mg/dl
Standard Deviation 22
|
|
Change in Lipid Levels
Final CT (12 months)
|
173 mg/dl
Standard Deviation 42
|
168 mg/dl
Standard Deviation 24
|
|
Change in Lipid Levels
Final TAG (12 months)
|
145 mg/dl
Standard Deviation 122
|
154 mg/dl
Standard Deviation 122
|
SECONDARY outcome
Timeframe: 12 monthsChange in body mass index (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
BMI (3 months)
|
43.5 kg/m2
Standard Deviation 40.3
|
44.4 kg/m2
Standard Deviation 41.5
|
|
Change in Body Mass Index (BMI)
Initial BMI
|
45.2 kg/m2
Standard Deviation 42.3
|
45.6 kg/m2
Standard Deviation 43.2
|
|
Change in Body Mass Index (BMI)
BMI (1 month)
|
44.1 kg/m2
Standard Deviation 41.2
|
45.4 kg/m2
Standard Deviation 42.5
|
|
Change in Body Mass Index (BMI)
BMI (6 months)
|
43.1 kg/m2
Standard Deviation 40.6
|
43.7 kg/m2
Standard Deviation 40.6
|
|
Change in Body Mass Index (BMI)
BMI (9 months)
|
43.3 kg/m2
Standard Deviation 41.6
|
43.3 kg/m2
Standard Deviation 40.5
|
|
Change in Body Mass Index (BMI)
Final BMI (12 months)
|
44.4 kg/m2
Standard Deviation 41.4
|
42.9 kg/m2
Standard Deviation 39.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange in cytokines using (dapaglifozin/metformin) vs. metformin.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Cytokines Level
Initial IL-10
|
6.34 pg/ml
Interval 2.44 to 17.67
|
3.09 pg/ml
Interval 1.66 to 13.29
|
|
Change in Cytokines Level
Initial IL-6
|
13.89 pg/ml
Interval 6.81 to 46.6
|
9.16 pg/ml
Interval 4.36 to 20.26
|
|
Change in Cytokines Level
Initial TNF-alfa
|
16.85 pg/ml
Interval 11.68 to 20.94
|
11.34 pg/ml
Interval 8.61 to 14.44
|
|
Change in Cytokines Level
Initial Resistin
|
2468.2 pg/ml
Interval 1912.7 to 3245.6
|
2503.75 pg/ml
Interval 1707.6 to 3691.3
|
|
Change in Cytokines Level
Final IL-10 (12 months)
|
8.46 pg/ml
Interval 2.9 to 28.4
|
4.06 pg/ml
Interval 1.66 to 8.35
|
|
Change in Cytokines Level
Final IL-6 (12 months)
|
15.69 pg/ml
Interval 6.71 to 56.8
|
6.43 pg/ml
Interval 4.38 to 23.65
|
|
Change in Cytokines Level
Final TNF-alfa (12 months)
|
16.59 pg/ml
Interval 11.55 to 23.11
|
10.02 pg/ml
Interval 8.35 to 13.46
|
|
Change in Cytokines Level
Final resistin (12 months)
|
2468.2 pg/ml
Interval 1912.7 to 3245.6
|
2344.98 pg/ml
Interval 1925.6 to 3263.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsChange in adiponectin using (dapaglifozin/metformin) vs. metformin.
Outcome measures
| Measure |
Metformin/Dapagliflozin
n=54 Participants
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 Participants
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Change in Adiponectin
Initial Adiponectin
|
68604.3 ng/ml
Interval 43943.1 to 102091.0
|
49880.4 ng/ml
Interval 35824.5 to 73390.2
|
|
Change in Adiponectin
Final adiponectin (12 months)
|
77119.2 ng/ml
Interval 59033.8 to 96640.6
|
63587.4 ng/ml
Interval 39261.4 to 81996.9
|
Adverse Events
Metformin/Dapagliflozin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin/Dapagliflozin
n=54 participants at risk
Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.
Dapagliflozin/Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
Metformin
n=55 participants at risk
Metformin 1,700 mg/day
Metformin: Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
|
|---|---|---|
|
Infections and infestations
Genital Tract Infections
|
27.8%
15/54 • Number of events 15 • 12 months.
|
14.5%
8/55 • Number of events 8 • 12 months.
|
Additional Information
Aldo Ferreira Hermosillo
UIM Enfermedades Endocrinas. Hospital de Especialidades Centro Médico Nacional Siglo XXI
Phone: +(52)15556276900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place