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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04131582
Recruitment Status : Unknown
Verified October 2019 by Rodolfo Guardado Mendoza, Universidad de Guanajuato.
Recruitment status was:  Recruiting
First Posted : October 18, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Hospital Regional de Alta Especialidad del Bajio
Information provided by (Responsible Party):
Rodolfo Guardado Mendoza, Universidad de Guanajuato

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prediabetic State Insulin Resistance Combination Product: Linagliptin + metformin and Empagliflozin + metformin Drug: Metformin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Assigned treatments will be delivered to the patients in identical envelopes by a person not involved in the trial; persons who evaluate the follow-up and outcomes will be masked to the treatment allocation
Primary Purpose: Prevention
Official Title: Effect of a Quadruple Therapy on Pancreatic Islet Function, Insulin Resistance and Cardiovascular Function in Patients With Mixed Prediabetes and Obesity: Randomized Clinical Trial
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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 Name: 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change from basal Weight at 6 and 12 months [ Time Frame: 6 and 12 months ]
    Weight measurement during the study, in kg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131582


Contacts
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Contact: Rodolfo Guardado-Mendoza, MDPhD 011524772672000 ext 1701 guardamen@gmail.com

Locations
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Mexico
Universidad de Guanajuato Recruiting
León, Guanajuato, Mexico, 37670
Contact: Rodolgo Guardado, MDPhD    4772674900 ext 3683    guardamen@gmail.com   
Contact: Jessica González, MIC    4772674900 ext 3683      
Sponsors and Collaborators
Universidad de Guanajuato
Hospital Regional de Alta Especialidad del Bajio
Investigators
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Principal Investigator: Rodolfo Guardado-Mendoza, MDPhD Universidad de Guanajuato
  Study Documents (Full-Text)

Documents provided by Rodolfo Guardado Mendoza, Universidad de Guanajuato:
Publications:

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Responsible Party: Rodolfo Guardado Mendoza, Principal Investigator, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT04131582    
Other Study ID Numbers: CI/HRAEB/2017/049
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data collection could be shared by the principal investigator on a particular request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodolfo Guardado Mendoza, Universidad de Guanajuato:
prediabetes
Additional relevant MeSH terms:
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Insulin Resistance
Prediabetic State
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia
Metformin
Empagliflozin
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors