Trial · NCT03968224
Effectiveness of Dapagliflozin for Weight Loss
NCT03968224, Phase 2, Phase 3, Completed, Centro Medico Nacional Siglo XXI IMSS; results first posted 2025-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Dapagliflozin for Weight Loss. Trials, record NCT03968224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03968224
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Dapagliflozin for Weight Loss
- NCT number
- NCT03968224
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 160 participants, actual
- Lead sponsor
- Centro Medico Nacional Siglo XXI IMSS
- Conditions
- PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
- Interventions
- Dapagliflozin/Metformin, Metformin
- First posted
- 2019-05-30
- Last updated
- 2025-10-15
- Results first posted
- 2025-10-15
- Limitations and caveats
- Delay in the study completion due COVID-19 pandemic. We were not able to measure glucagon and ghrelin concentrations.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Weight | 12 months | Change in weight using (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months. |
| Secondary | Change in Blood Pressure | 12 months | Change in blood pressure using (dapaglifozin/metformin) vs. metformin at three, six, nine and twelve months. |
| Secondary | Change in Waist Circumference | 12 months | Change in waist circumference in (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months. |
| Secondary | Change in Lipid Levels | 12 months | Change in lipid levels using (dapaglifozin/metformin) vs. metformin in three, six, nine and twelve months. |
| Secondary | Change in Body Mass Index (BMI) | 12 months | Change in body mass index (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months. |
| Other | Change in Cytokines Level | 12 months | Change in cytokines using (dapaglifozin/metformin) vs. metformin. |
| Other | Change in Adiponectin | 12 months | Change in adiponectin using (dapaglifozin/metformin) vs. metformin. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Weight | 12 months | kg | MEAN | |
| SECONDARY | Change in Blood Pressure | 12 months | mmHg | MEAN | |
| SECONDARY | Change in Waist Circumference | 12 months | cm | MEAN | |
| SECONDARY | Change in Lipid Levels | 12 months | mg/dl | MEAN | |
| OTHER_PRE_SPECIFIED | Change in Cytokines Level | 12 months | pg/ml | MEAN | |
| OTHER_PRE_SPECIFIED | Change in Adiponectin | 12 months | ng/ml | MEAN | |
| SECONDARY | Change in Body Mass Index (BMI) | 12 months | kg/m2 | MEAN |
Source ClinicalTrials.gov
Results by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Weight | Metformin/Dapagliflozin | Initial weight | 121.5 | Standard Deviation 21.1 | kg |
| Change in Weight | Metformin | Initial weight | 125.9 | Standard Deviation 23.9 | kg |
| Change in Weight | Metformin/Dapagliflozin | Weight (1 month) | 118 | Standard Deviation 20.8 | kg |
| Change in Weight | Metformin | Weight (1 month) | 123.7 | Standard Deviation 21.8 | kg |
| Change in Weight | Metformin/Dapagliflozin | Weight (3 months) | 116.3 | Standard Deviation 20.11 | kg |
| Change in Weight | Metformin | Weight (3 months) | 120 | Standard Deviation 20.58 | kg |
| Change in Weight | Metformin/Dapagliflozin | Weight (6 months) | 114.4 | Standard Deviation 17.8 | kg |
| Change in Weight | Metformin | Weight (6 months) | 119.9 | Standard Deviation 22.4 | kg |
| Change in Weight | Metformin/Dapagliflozin | Weight (9 months) | 115.4 | Standard Deviation 17.9 | kg |
| Change in Weight | Metformin | Weight (9 months) | 118.4 | Standard Deviation 21.4 | kg |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin/Dapagliflozin | 54 | |
| Overall Study | STARTED | Metformin | 55 | |
| Overall Study | COMPLETED | Metformin/Dapagliflozin | 43 | |
| Overall Study | COMPLETED | Metformin | 37 | |
| Overall Study | NOT COMPLETED | Metformin/Dapagliflozin | 11 | |
| Overall Study | NOT COMPLETED | Metformin | 18 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Genital Tract Infections | Infections and infestations | Metformin/Dapagliflozin | 15 | 54 | 15 |
| other | Genital Tract Infections | Infections and infestations | Metformin | 8 | 55 | 8 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin/Dapagliflozin | 0 | 54 |
| Total, all-cause mortality | Metformin | 0 | 55 |
| Total, other adverse events | Metformin/Dapagliflozin | 15 | 54 |
| Total, other adverse events | Metformin | 8 | 55 |
| Total, serious adverse events | Metformin/Dapagliflozin | 0 | 54 |
| Total, serious adverse events | Metformin | 0 | 55 |
Source ClinicalTrials.gov
Papers89
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metformin/Dapagliflozin vs Metformin: deaths from any cause | Trial comparisons |
| Metformin/Dapagliflozin vs Metformin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03968224
GET https://conductscience.org/api/trials/v1/NCT03968224/results?page=2