PreDiabetesPhase 2/3NCT03968224
Effectiveness of Dapagliflozin for Weight Loss
A Phase 2/3 study testing Dapagliflozin/Metformin and Metformin in people with PreDiabetes and Obesity, Morbid, run by Centro Medico Nacional Siglo XXI IMSS at 1 site in Mexico.
Trial summary
Mexico has one of the highest prevalence of obesity, reported on 32.4 percent of people over 20 years old, with a prevalence of obesity class III of 1.8 percent on males and 4.1 percent on females. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin/Metformin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMexico
- Study dates
- 4 Aug 2018to 31 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI greater than or equal to 40 kg/m^2
- Diagnosis of diabetes or prediabetes according to the criteria of the ADA
- Patients who sign informed consent letter
Who cannot join
- Use of insulin or sulfonylureas
- Chronic renal failure with glomerular filtration rate <60 ml/min/1.73 m^2
- Use of loop diuretics with no possibility to suspend
- Active genitourinary tract infections determined by symptomatology or urinalysis
- Use of drugs for weight control
- Patients with untreated or uncontrolled hypothyroidism
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Especialidades Centro Médico Nacional Siglo XXI
Mexico City, 06720
About this study
Official title: Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III
Mexico has one of the highest prevalence of obesity, reported on 32.4 percent of people over 20 years old, with a prevalence of obesity class III of 1.8 percent on males and 4.1 percent on females.
According to previous data in our Obesity Clinic the mean age of these patients is 41 years, 46 percent have pre-diabetes or type 2 diabetes mellitus (T2D); 66 percent has hypertension and 33 percent has dyslipidemia. The management of alterations in the glucose metabolism in this unit is made by dietary treatment and with the use of metformin at doses of 1,700 mg/day and/or basal insulin.
Read more
Dapagliflozin is a selective SGLT2 inhibitor than has shown a sustained effect on the reduction of glycated hemoglobin at 0.4 to 0.8 percent (initial 7.8 to 8.0 percent). Additionally, due to the induction of glycosuria up to 20 to 85 g/day, it has been calculated that its use induces a caloric deficit at 80 to 340 kcal/day. This has been tested in patients with T2D in which induces a weight loss of 2 to 3 kg and in combination with metformin even a weight loss up to 5.07 kg (-6.21 to 3.93 kg) without regain (at least for 2 years). Furthermore, dapagliflozin decrease systolic blood pressure, increases HDL cholesterol concentrations and decreases triglyceride concentration. The drug product action is independent of the insulin production at pancreas, consequently, it exists a possibility of using the drug product on patients with prediabetes or even on other types of diabetes. Regarding the adverse effects related to its use, it has been described an increase in the risk of genitourinary infections with a low risk for inducing hypoglycemia.
A previous study that included 182 patients with T2D inadequately controlled with metformin assessed the effect of dapagliflozin 10 mg in total weight loss after 24 weeks compared to placebo. It was found a decrease in weight of 2.08 kg (2.8 to 1.31 kg), decrease in waist circumference of 1.52 cm (2.74 to 0.31), decrease in total fat mass assessed with densitometry of 1.48 kg (2.22 to 0.74), decrease of visceral fat mass of 258.4 cm^3 (448.1 to 68.6) and subcutaneous fat of 184.9 cm^3 (359.7 to 10.1). Most of these studies on weight and metabolic control have been performed in patients with obesity class II or I. The aim of this study is to assess if dapagliflozin in combination with metformin is at least 10 percent more effective for weight reduction in comparison with metformin in patients with prediabetes or T2D and obesity grade III.
Read the detailed description
Methods:
A convenience sampling will be done for patients diagnosed with diabetes or prediabetes according to the American Diabetes Association (ADA) criteria, who assist to the Obesity Clinic and meet the selection criteria. Data from patients that during the study protocol are called to undergo bariatric surgery procedure will be used until the time of surgery (intention-to-treat analysis). The prevalence of comorbidities at baseline and the type and dose of drugs used for treatment will be recorded. Patients will be randomized by a random numbers system generated with a computational software and will be assigned to a group: metformin (1,700 mg/day) or metformin (1,700 mg/day) and dapagliflozin 10 mg. All patients will receive dietary treatment and follow-up during the study by the Nutrition Service. Once assigned to the corresponding group, patients will receive an identification code that will be retained throughout the study. One of the researchers not directly involved in patient care, will assign tablets needed for daily intake for a month and then the number of tablets required for 3 months in a sealed envelope. A run-in period will be used to assess tolerance to treatments. This period will be for a month. At this time patients may notice an increase of uresis and will be instructed to increase fluid intake. Anthropometric and biochemical variables will be recorded baseline and at 1, 3, 6 and 12 months. The determination of glucagon, ghrelin, adiponectin, resistin, interleukin 6 (IL-6) and interleukin 10 (IL-10) will be held on initial appointment and before surgery (depending on the response of each patient). For the determination of these cytokines and peptides, an ELISA kit (Enzyme Linked Immunosorbent Assay) will be used. Adherence to treatment will be evaluated and will consist in consumption of 90 percent of pills granted. The patient will be required to return the drug blister. The registration of adverse events will take place from the start of treatment and throughout the study. Each event will be evaluated by researchers and classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 list. CTCAE considers that an adverse event grade 4 or 5 indicates discontinuation of treatment; grade 3 must be submitted to review by the medical team, and grades 1 or 2 require registration and intervention but not discontinuation of treatment. Adverse events will be recorded in the report sheet. An intention-to-treat analysis will be used if patients require treatment with insulin or sulfonylureas (grade 3 adverse event). They will provide information until the time of its inception. Patients who do not achieve weight loss at one year follow-up, will be discarded to their primary care hospital for continue with dietary recommendations.
Sample Size:
A convenience sample will be performed of patients with obesity class III and prediabetes or diabetes according ADA criteria at Obesity Clinic who meet selection criteria. The sample size was calculated using a mean difference formula with data from Zhang et al. who evaluated weight loss in patients using metformin/dapagliflozin and compared with placebo. Sample size required is 90 patients: 45 patients in metformin group and 45 patients in dapagliflozin/metformin group. Considering a loss of 20 percent of population during study, the final sample size required is 108 patients: 54 patients in metformin and 54 patients in dapagliflozin group.
Statistical analysis Quantitative variables were described using measures of central tendency and dispersion according to the data distributions. Qualitative variables were described using frequencies or percentages. The Shapiro-Wilk test was used to establish normality in the distribution of quantitative variables. Because information on the different quantitative variables was available up to different time periods, a mixed model analysis was performed using the restricted maximum likelihood (REML) method, as well as a mixed model considering the fixed effects of assigned treatment, sex, and prediabetes or diabetes status, and the random effects of variability in weight loss over time. Comparisons between groups were analyzed using Sidak's post-hoc test. Pearson's chi-square test or Fisher's exact test were used to evaluate the association between qualitative variables. Statistical significance was defined as a p < 0.05. Data analysis was performed using SPSS version 17.0 and STATA version 11.0.
- Conditions
- PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin/Metformin, Metformin
- Keywords
- Metformin, Sodium-Glucose Transporter 2 Inhibitors, PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
- Medical subject headings
- Prediabetic State, Obesity, Morbid, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin/MetforminDrug
Also called Group 1
Two tablets of Metformin 850 mg every 12 hours were provided in combination with Dapagliflozin 10 mg per day. Each participant received diet and exercise intervention according to their BMI and current physical condition.
MetforminDrug
Also called Group 2
Two tablets of Metformin 850 mg every 12 hours were provided. Each participant received diet and exercise intervention according to their BMI and current physical condition.
| Study group | Role | What they receive |
|---|---|---|
| Metformin/Dapagliflozin | Experimental | Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year. Receives: Drug: Dapagliflozin/Metformin |
| Metformin | Active comparator | Metformin 1,700 mg/day Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Change in weight using (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Measured: 12 months
Secondary outcomes (4)
Change in Blood Pressure
Change in blood pressure using (dapaglifozin/metformin) vs. metformin at three, six, nine and twelve months.
Measured: 12 months
Change in Waist Circumference
Change in waist circumference in (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Measured: 12 months
Change in Lipid Levels
Change in lipid levels using (dapaglifozin/metformin) vs. metformin in three, six, nine and twelve months.
Measured: 12 months
Change in Body Mass Index (BMI)
Change in body mass index (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start4 Aug 2018
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (89)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel group controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Medico Nacional Siglo XXI IMSS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldo Ferreira Hermosillo, Centro Medico Nacional Siglo XXI IMSS
- Investigators
- Moises Mercado, PhD, Principal investigatorAldo Ferreira-Hermosillo, PhD, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968224
- Sponsor's protocol ID
- R-2016-785-094
- Status last verified
- Sep 2025
- First submitted
- 27 May 2019
- Last updated
- 15 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request to principal investigator
Publications
Barrera-Cruz A, Avila-Jimenez L, Cano-Perez E, Molina-Ayala MA, Parrilla-Ortiz JI, Ramos-Hernandez RI, Sosa-Caballero A, Sosa-Ruiz Mdel R, Gutierrez-Aguilar J. [Practice clinical guideline. Prevention, diagnosis and treatment of overweight and obesity]. Rev Med Inst Mex Seguro Soc. 2013 May-Jun;51(3):344-57. Spanish.
PubMed 23883468Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459Mason EE, Doherty C, Maher JW, Scott DH, Rodriguez EM, Blommers TJ. Super obesity and gastric reduction procedures. Gastroenterol Clin North Am. 1987 Sep;16(3):495-502.
PubMed 3436656Nguyen NT, Ho HS, Palmer LS, Wolfe BM. Laparoscopic Roux-en-Y gastric bypass for super/super obesity. Obes Surg. 1999 Aug;9(4):403-6. doi: 10.1381/096089299765553025.
PubMed 10484302Romero-Martinez M, Shamah-Levy T, Cuevas-Nasu L, Gomez-Humaran IM, Gaona-Pineda EB, Gomez-Acosta LM, Rivera-Dommarco JA, Hernandez-Avila M. [Methodological design of the National Health and Nutrition Survey 2016]. Salud Publica Mex. 2017 May-Jun;59(3):299-305. doi: 10.21149/8593. Spanish.
PubMed 28902317Barrera-Cruz A, Rodriguez-Gonzalez A, Molina-Ayala MA. [The current state of obesity in Mexico]. Rev Med Inst Mex Seguro Soc. 2013 May-Jun;51(3):292-9. Spanish.
PubMed 23883458Rizzello M, De Angelis F, Campanile FC, Silecchia G. Effect of gastrointestinal surgical manipulation on metabolic syndrome: a focus on metabolic surgery. Gastroenterol Res Pract. 2012;2012:670418. doi: 10.1155/2012/670418. Epub 2012 Oct 22.
PubMed 23133447Barquera S, Campos-Nonato I, Hernandez-Barrera L, Pedroza A, Rivera-Dommarco JA. [Prevalence of obesity in Mexican adults 2000-2012]. Salud Publica Mex. 2013;55 Suppl 2:S151-60. Spanish.
PubMed 24626691Santo MA, Riccioppo D, Pajecki D, Cleva Rd, Kawamoto F, Cecconello I. Preoperative weight loss in super-obese patients: study of the rate of weight loss and its effects on surgical morbidity. Clinics (Sao Paulo). 2014;69(12):828-34. doi: 10.6061/clinics/2014(12)07.
PubMed 25627995American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
PubMed 30559228American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.
PubMed 30559235Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10.1210/jc.2014-3415. Epub 2015 Jan 15.
PubMed 25590212Yanovski SZ, Yanovski JA. Long-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014 Jan 1;311(1):74-86. doi: 10.1001/jama.2013.281361.
PubMed 24231879Idris I, Donnelly R. Sodium-glucose co-transporter-2 inhibitors: an emerging new class of oral antidiabetic drug. Diabetes Obes Metab. 2009 Feb;11(2):79-88. doi: 10.1111/j.1463-1326.2008.00982.x.
PubMed 19125776Shepherd PR, Kahn BB. Glucose transporters and insulin action--implications for insulin resistance and diabetes mellitus. N Engl J Med. 1999 Jul 22;341(4):248-57. doi: 10.1056/NEJM199907223410406. No abstract available.
PubMed 10413738
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III
- ClinicalTrials.gov ID
- NCT03968224
- Acronym / sponsor ID
- R-2016-785-094
- Conditions
- PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
- Keywords
- Metformin, Sodium-Glucose Transporter 2 Inhibitors, PreDiabetes, Obesity, Morbid, Diabetes Mellitus, Type 2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Centro Medico Nacional Siglo XXI IMSSUniversity, hospital or other
- Study start
- 4 Aug 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mexico has one of the highest prevalence of obesity, reported on 32.4 percent of people over 20 years old, with a prevalence of obesity class III of 1.8 percent on males and 4.1 percent on females.
According to previous data in our Obesity Clinic the mean age of these patients is 41 years, 46 percent have pre-diabetes or type 2 diabetes mellitus (T2D); 66 percent has hypertension and 33 percent has dyslipidemia. The management of alterations in the glucose metabolism in this unit is made by dietary treatment and with the use of metformin at doses of 1,700 mg/day and/or basal insulin.
Dapagliflozin is a selective SGLT2 inhibitor than has shown a sustained effect on the reduction of glycated hemoglobin at 0.4 to 0.8 percent (initial 7.8 to 8.0 percent). Additionally, due to the induction of glycosuria up to 20 to 85 g/day, it has been calculated that its use induces a caloric deficit at 80 to 340 kcal/day. This has been tested in patients with T2D in which induces a weight loss of 2 to 3 kg and in combination with metformin even a weight loss up to 5.07 kg (-6.21 to 3.93 kg) without regain (at least for 2 years). Furthermore, dapagliflozin decrease systolic blood pressure, increases HDL cholesterol concentrations and decreases triglyceride concentration. The drug product action is independent of the insulin production at pancreas, consequently, it exists a possibility of using the drug product on patients with prediabetes or even on other types of diabetes. Regarding the adverse effects related to its use, it has been described an increase in the risk of genitourinary infections with a low risk for inducing hypoglycemia.
A previous study that included 182 patients with T2D inadequately controlled with metformin assessed the effect of dapagliflozin 10 mg in total weight loss after 24 weeks compared to placebo. It was found a decrease in weight of 2.08 kg (2.8 to 1.31 kg), decrease in waist circumference of 1.52 cm (2.74 to 0.31), decrease in total fat mass assessed with densitometry of 1.48 kg (2.22 to 0.74), decrease of visceral fat mass of 258.4 cm^3 (448.1 to 68.6) and subcutaneous fat of 184.9 cm^3 (359.7 to 10.1). Most of these studies on weight and metabolic control have been performed in patients with obesity class II or I. The aim of this study is to assess if dapagliflozin in combination with metformin is at least 10 percent more effective for weight reduction in comparison with metformin in patients with prediabetes or T2D and obesity grade III.
Detailed description
Methods:
A convenience sampling will be done for patients diagnosed with diabetes or prediabetes according to the American Diabetes Association (ADA) criteria, who assist to the Obesity Clinic and meet the selection criteria. Data from patients that during the study protocol are called to undergo bariatric surgery procedure will be used until the time of surgery (intention-to-treat analysis). The prevalence of comorbidities at baseline and the type and dose of drugs used for treatment will be recorded. Patients will be randomized by a random numbers system generated with a computational software and will be assigned to a group: metformin (1,700 mg/day) or metformin (1,700 mg/day) and dapagliflozin 10 mg. All patients will receive dietary treatment and follow-up during the study by the Nutrition Service. Once assigned to the corresponding group, patients will receive an identification code that will be retained throughout the study. One of the researchers not directly involved in patient care, will assign tablets needed for daily intake for a month and then the number of tablets required for 3 months in a sealed envelope. A run-in period will be used to assess tolerance to treatments. This period will be for a month. At this time patients may notice an increase of uresis and will be instructed to increase fluid intake. Anthropometric and biochemical variables will be recorded baseline and at 1, 3, 6 and 12 months. The determination of glucagon, ghrelin, adiponectin, resistin, interleukin 6 (IL-6) and interleukin 10 (IL-10) will be held on initial appointment and before surgery (depending on the response of each patient). For the determination of these cytokines and peptides, an ELISA kit (Enzyme Linked Immunosorbent Assay) will be used. Adherence to treatment will be evaluated and will consist in consumption of 90 percent of pills granted. The patient will be required to return the drug blister. The registration of adverse events will take place from the start of treatment and throughout the study. Each event will be evaluated by researchers and classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 list. CTCAE considers that an adverse event grade 4 or 5 indicates discontinuation of treatment; grade 3 must be submitted to review by the medical team, and grades 1 or 2 require registration and intervention but not discontinuation of treatment. Adverse events will be recorded in the report sheet. An intention-to-treat analysis will be used if patients require treatment with insulin or sulfonylureas (grade 3 adverse event). They will provide information until the time of its inception. Patients who do not achieve weight loss at one year follow-up, will be discarded to their primary care hospital for continue with dietary recommendations.
Sample Size:
A convenience sample will be performed of patients with obesity class III and prediabetes or diabetes according ADA criteria at Obesity Clinic who meet selection criteria. The sample size was calculated using a mean difference formula with data from Zhang et al. who evaluated weight loss in patients using metformin/dapagliflozin and compared with placebo. Sample size required is 90 patients: 45 patients in metformin group and 45 patients in dapagliflozin/metformin group. Considering a loss of 20 percent of population during study, the final sample size required is 108 patients: 54 patients in metformin and 54 patients in dapagliflozin group.
Statistical analysis Quantitative variables were described using measures of central tendency and dispersion according to the data distributions. Qualitative variables were described using frequencies or percentages. The Shapiro-Wilk test was used to establish normality in the distribution of quantitative variables. Because information on the different quantitative variables was available up to different time periods, a mixed model analysis was performed using the restricted maximum likelihood (REML) method, as well as a mixed model considering the fixed effects of assigned treatment, sex, and prediabetes or diabetes status, and the random effects of variability in weight loss over time. Comparisons between groups were analyzed using Sidak's post-hoc test. Pearson's chi-square test or Fisher's exact test were used to evaluate the association between qualitative variables. Statistical significance was defined as a p < 0.05. Data analysis was performed using SPSS version 17.0 and STATA version 11.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel group controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Metformin/Dapagliflozin | Experimental | Drug: Dapagliflozin/MetforminMetformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year. |
| Metformin | Active comparator | Drug: MetforminMetformin 1,700 mg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI greater than or equal to 40 kg/m^2
- Diagnosis of diabetes or prediabetes according to the criteria of the ADA
- Patients who sign informed consent letter
Key exclusion criteria (6 listed)
- Use of insulin or sulfonylureas
- Chronic renal failure with glomerular filtration rate <60 ml/min/1.73 m^2
- Use of loop diuretics with no possibility to suspend
- Active genitourinary tract infections determined by symptomatology or urinalysis
- Use of drugs for weight control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin/MetforminAlso: Group 1Two tablets of Metformin 850 mg every 12 hours were provided in combination with Dapagliflozin 10 mg per day. Each participant received diet and exercise intervention according to their BMI and current physical condition. | Drug | Metformin/Dapagliflozin |
| MetforminAlso: Group 2Two tablets of Metformin 850 mg every 12 hours were provided. Each participant received diet and exercise intervention according to their BMI and current physical condition. | Drug | Metformin |
Primary outcome
Change in Weight
Time frame: 12 months
Change in weight using (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.
4 secondary outcomes
Change in Blood Pressure
Time frame: 12 months
Change in Waist Circumference
Time frame: 12 months
Change in Lipid Levels
Time frame: 12 months
Change in Body Mass Index (BMI)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23883468Barrera-Cruz A, Avila-Jimenez L, Cano-Perez E, Molina-Ayala MA, Parrilla-Ortiz JI, Ramos-Hernandez RI, Sosa-Caballero A, Sosa-Ruiz Mdel R, Gutierrez-Aguilar J. [Practice clinical guideline. Prevention, diagnosis and treatment of overweight and obesity]. Rev Med Inst Mex Seguro Soc. 2013 May-Jun;51(3):344-57. Spanish.
- Background: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Background: PubMed 3436656Mason EE, Doherty C, Maher JW, Scott DH, Rodriguez EM, Blommers TJ. Super obesity and gastric reduction procedures. Gastroenterol Clin North Am. 1987 Sep;16(3):495-502.
- Background: PubMed 10484302Nguyen NT, Ho HS, Palmer LS, Wolfe BM. Laparoscopic Roux-en-Y gastric bypass for super/super obesity. Obes Surg. 1999 Aug;9(4):403-6. doi: 10.1381/096089299765553025.
- Background: PubMed 28902317Romero-Martinez M, Shamah-Levy T, Cuevas-Nasu L, Gomez-Humaran IM, Gaona-Pineda EB, Gomez-Acosta LM, Rivera-Dommarco JA, Hernandez-Avila M. [Methodological design of the National Health and Nutrition Survey 2016]. Salud Publica Mex. 2017 May-Jun;59(3):299-305. doi: 10.21149/8593. Spanish.
- Background: PubMed 23883458Barrera-Cruz A, Rodriguez-Gonzalez A, Molina-Ayala MA. [The current state of obesity in Mexico]. Rev Med Inst Mex Seguro Soc. 2013 May-Jun;51(3):292-9. Spanish.
- Background: PubMed 23133447Rizzello M, De Angelis F, Campanile FC, Silecchia G. Effect of gastrointestinal surgical manipulation on metabolic syndrome: a focus on metabolic surgery. Gastroenterol Res Pract. 2012;2012:670418. doi: 10.1155/2012/670418. Epub 2012 Oct 22.
- Background: PubMed 24626691Barquera S, Campos-Nonato I, Hernandez-Barrera L, Pedroza A, Rivera-Dommarco JA. [Prevalence of obesity in Mexican adults 2000-2012]. Salud Publica Mex. 2013;55 Suppl 2:S151-60. Spanish.
- Background: PubMed 25627995Santo MA, Riccioppo D, Pajecki D, Cleva Rd, Kawamoto F, Cecconello I. Preoperative weight loss in super-obese patients: study of the rate of weight loss and its effects on surgical morbidity. Clinics (Sao Paulo). 2014;69(12):828-34. doi: 10.6061/clinics/2014(12)07.
- Background: PubMed 30559228American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.
- Background: PubMed 30559235American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009.
- Background: PubMed 25590212Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U, Ryan DH, Still CD; Endocrine Society. Pharmacological management of obesity: an endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2015 Feb;100(2):342-62. doi: 10.1210/jc.2014-3415. Epub 2015 Jan 15.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request to principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moises Mercado, PhD principal investigator
Aldo Ferreira-Hermosillo, PhD principal investigator
Unafilliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin/Metformin and Metformin in people with PreDiabetes and Obesity, Morbid, run by Centro Medico Nacional Siglo XXI IMSS at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968224, which also lists 89 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.