Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes (4T)

October 17, 2019 updated by: Rodolfo Guardado Mendoza, Universidad de Guanajuato

Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main goal of this clinical trial is to compare the effect of two different treatments during 12 months:

  1. Lifestyle modification program + metformin 850 mg twice daily
  2. Lifestyle modification program empagliflozin (12.5 mg) + metformin (850 mg) once daily plus linagliptin (2.5 mg) + metformin (850 mg) once daily On the following parameters, after 12 months of treatment

1) Glucose metabolism, evaluated by oral glucose tolerance test 2) Insulin resistance evaluated by the oral glucose tolerance 3) Insulin secretion, evaluated by the oral glucose tolerance 4) Pancreatic beta cell function, evaluated by the oral glucose tolerance test 5) Cardiovascular function, evaluated by standard echocardiography by left ventricular ejection fraction

All the patients will have a basal evaluation with an oral glucose tolerance test, lipid profile and body composition measurement by dual energy X-ray absorptiometry (DEXA). After the basal evaluation, if the patients results with impaired fasting glucose and impaired glucose tolerance, they will be invited to the intervention phase where they will be randomized to one of the two treatment groups.

Patients will have a follow-up visit every month to review the adherence to the lifestyle modification program and to the medication, and every 6 months an OGTT. After 12 months , patients will repeat the same evaluation performed at basal.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37670
        • Recruiting
        • Universidad de Guanajuato
        • Contact:
        • Contact:
          • Jessica González, MIC
          • Phone Number: 3683 4772674900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with prediabetes, defined for the existence impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Tolerance Glucose Test (OGTT) with impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
  • Patients who accept to participate in the study and sign the informed consent letter.

Exclusion Criteria:

  • Patients with diagnosed Type 2 Diabetes previously or detected during the OGTT
  • Patients in actual treatment or during the last 3 months with metformin, pioglitazone or another antidiabetic drug, including insulin
  • Serum creatinine > 1.6 mg/dL
  • Hypertriglyceridemia very high (>500 mg/dL)
  • Pregnant women
  • Altered arterial hypertension (Systolic >180 mmHg or Diastolic >105 mmHg)
  • Excessive alcohol intake, acute or chronic
  • Medications or medical conditions that affect glucose homeostasis (thiazides, beta blockers, glucocorticoids for systemic use, weight-reducing drugs or anorexigenics, Cushing´s syndrome, thyrotoxicosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Combination product: Linagliptin + metformin and Empagliflozin + metformin
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
Other Names:
  • Trayenta Duo + Jardianz Duo
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
Drug: Metformin
Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from basal fasting and post2h OGTT glucose levels at 6 and 12 months
Time Frame: 6 and 12 months
Fasting and post-2h OGTT glucose values (mg/dl)
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from basal pancreatic beta cell function at 6 and 12 months
Time Frame: 6 and 12 months
Evaluated with the measurements of glucose and insulin during the oral glucose tolerance
6 and 12 months
Change from basal insulin sensitivity at 6 and 12 months
Time Frame: 6 and 12 months
Insulin sensitivity evaluated during the oral glucose tolerance test by Matsuda index
6 and 12 months
Change from basal Weight at 6 and 12 months
Time Frame: 6 and 12 months
Weight measurement during the study, in kg
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Guanajuato

Collaborators

Hospital Regional de Alta Especialidad del Bajio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

December 15, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI/HRAEB/2017/049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data collection could be shared by the principal investigator on a particular request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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