Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes

Sponsor
Universidad de Guanajuato
Study ID
NCT04131582
Phase
PHASE3
Status
Unknown

Conditions

  • Insulin Resistance
  • Prediabetic State

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Linagliptin + metformin and Empagliflozin + metformin — COMBINATION_PRODUCT
    Linagliptin-Metformin 2.5/850mg once daily, Empagliflozin-Metformin 12.5/850mg one daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
  • Metformin — DRUG
    Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling

Study Details

Type 2 diabetes is a worldwide epidemic disease, and preventive strategies are needed to face this health problem. The goal of this trial is to evaluate the effect of empagliflozin + linagliptin + metformin + lifestyle on physiopathological parameters, sush as glucose metabolism, insulin resistance, pancreatic beta cell function and cardiovascular function in patients with impaired fasting glucose plus impaired glucose tolerance, during 12 months

Key Dates

Start date
Sep 1, 2019
Status verified
Oct 2019
Primary completion
Dec 15, 2020
Completion
Dec 30, 2020

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Empagliflozin + linagliptin + metformin plus lifestyle
    Patients are randomized to receive for 12 months Linagliptin 2.5 mg + metformin 850 mg every 12 hours and empagliflozin 12.5 mg + metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the full doses. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week
  • Active Comparator: Metformin plus lifestyle
    Patients are randomized to receive for 12 months Metformin 850 mg every 12 hours. The start of the dose in this group will be gradual so that at the month of treatment the patient can be with the complete dose. Together with this, patients will receive a lifestyle modification program seeking to reduce 5-7% of body weigh and increase physical activity to 90/150 min/week

Primary Outcome Measure

Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months [ Time Frame: 6 and 12 months ]

Central Contacts

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