Effectiveness of Dapagliflozin for Weight Loss

NCT03968224 | Completed Phase 2 Results

• 1 other identifier: R-2016-785-094
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PreDiabetes; Obesity, Morbid; Diabetes Mellitus, Type 2

Keywords

Metformin; Sodium-Glucose Transporter 2 Inhibitors; PreDiabetes; Obesity, Morbid; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Change in weight using (dapaglifozin/metformin) vs. metformin at one, three, six, nine and twelve months.

  12 months

Secondary Outcomes (4)

• Change in Blood Pressure

  12 months

• Change in Waist Circumference

  12 months

• Change in Lipid Levels

  12 months

• Change in Body Mass Index (BMI)

  12 months

Other Outcomes (2)

• Change in Cytokines Level

  12 months

• Change in Adiponectin

  12 months

Study Arms (2)

Metformin/Dapagliflozin

EXPERIMENTAL

Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.

Drug: Dapagliflozin/Metformin

Metformin

ACTIVE COMPARATOR

Metformin 1,700 mg/day

Drug: Metformin

Interventions

Dapagliflozin/Metformin DRUG

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.

Also known as: Group 1

Metformin/Dapagliflozin

Metformin DRUG

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.

Also known as: Group 2

Metformin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Medico Nacional Siglo XXI IMSS: lead

Study Sites (1)

Hospital de Especialidades Centro Médico Nacional Siglo XXI

Mexico City, 06720, Mexico

Location

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MeSH Terms

Conditions

Prediabetic State; Obesity, Morbid; Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

Delay in the study completion due COVID-19 pandemic. We were not able to measure glucagon and ghrelin concentrations.

Results Point of Contact

• Title: Aldo Ferreira Hermosillo
• Organization: UIM Enfermedades Endocrinas. Hospital de Especialidades Centro Médico Nacional Siglo XXI

aferreira@endocrinologia.org.mx

+(52)15556276900

Study Officials

• Moises Mercado, PhD

  PRINCIPAL INVESTIGATOR

• Aldo Ferreira-Hermosillo, PhD

  Unafilliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Randomized, parallel group controlled clinical trial

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: August 4, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)