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Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity

NCT03710460 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-05-23

No results posted yet for this study

Summary

Obesity has increased to alarming levels in the world. Currently it is estimated that it occurs in a third of the world's population and it is expected that by 2030, 20% of the world's adult population will suffer from obesity and 38% will be overweight, and it is important to highlight that Mexico is among the first in obesity in adults and children.

Obesity leads to the development of diseases such as diabetes mellitus type 2, dyslipidemias, metabolic syndrome, heart problems, among others.

The treatment for obesity in the first instance are changes in lifestyle, changes in diet and exercise that have shown, in most patients, have little long-term adherence. There are also drugs that promote weight loss by modifying the appetite or absorption of macronutrients.

Dapagliflozin plus metformin XR is a medicine composed with an oral antidiabetic of the group of inhibitors of SGLT2 that has shown to have significant side effects in the weight reduction and visceral adiposity in people with obesity and in patients with diabetes mellitus type 2, it is also composed with metformin which also has effects on weight loss in people with and without type 2 diabetes mellitus.

For these reasons, evaluating this compound drug in people with obesity could provide high impact information as a complement for the treatment of this condition when compared to the effects produced by monotherapies.

Conditions

Interventions

DRUG

Dapagliflozin

10 mg, one per day before breakfast during 12 weeks.

DRUG

Dapagliflozin plus Metformin XR

10/1000 mg, one per day before breakfast during 12 weeks.

DRUG

Metformin XR

1000 mg, one per day before breakfast during 12 weeks.

Sponsors & Collaborators

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Manuel Gonzalez Ortiz, MD MSc Phd · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
31 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Mexico

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710460 on ClinicalTrials.gov