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

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de Guanajuato
• Collaborator: Hospital Regional de Alta Especialidad del Bajio
• Treatments: Empagliflozin; Linagliptin; Metformin

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