Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes
NCT ID: NCT04131582
Last Updated: 2019-10-21
Study Results
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Basic Information
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UNKNOWN
PHASE3
34 participants
INTERVENTIONAL
2019-09-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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
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
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
Metformin
Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
Interventions
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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
Metformin
Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who accept to participate in the study and sign the informed consent letter.
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hospital Regional de Alta Especialidad del Bajio
OTHER
Universidad de Guanajuato
OTHER
Responsible Party
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Rodolfo Guardado Mendoza
Principal Investigator
Principal Investigators
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Rodolfo Guardado-Mendoza, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Guanajuato
Locations
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Universidad de Guanajuato
León, Guanajuato, Mexico
Countries
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Central Contacts
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Facility Contacts
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Jessica González, MIC
Role: backup
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CI/HRAEB/2017/049
Identifier Type: -
Identifier Source: org_study_id
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