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

Sponsor
University of Guadalajara
Study ID
NCT03710460
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
31 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg, one per day before breakfast during 12 weeks.
  • Dapagliflozin plus Metformin XR — DRUG
    10/1000 mg, one per day before breakfast during 12 weeks.
  • Metformin XR — DRUG
    1000 mg, one per day before breakfast during 12 weeks.

Study Details

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.

Key Dates

Start date
Jul 30, 2019
Status verified
Jun 2022
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
  • Experimental: Dapagliflozin plus metformin XR
    Dapagliflozin plus metformin XR capsules, 10/1000 mg, one per day before breakfast during 12 weeks.
  • Experimental: Metformin XR
    Metformin XR capsules, 1000 mg, one per day before breakfast during 12 weeks.

Primary Outcome Measure

Body Weight [ Time Frame: Baseline to week 12 ]

Central Contacts

Related Studies