Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this protocol is to evaluate the effect of addhing linagliptin to patients with prediabetes who do not reverse to normoglycemia after 12 months of treatment with metformin alone. The duration of the study will be 6 months, and it is primarily a efficacy study. Main outcomes will be glucose levels during OGTT, insulin secretion and pancreatic beta cell function measured by the disposition index derived from the OGTT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patients with impaired glucose tolerance (2 h glucose between 140 - 199 mg / dL) that after 1 year of treatment with metformin at a dose of 1700 mg daily + lifestyle modifications don't achieve normoglycemia.

• Patients who accept to participate in the study and sign informed consent.

Exclusion Criteria:

• Patients with type 2 Diabetes diagnosted previuosly or detected during the OGTT

• Serum creatinine > 1.6 mg/dL

• Hypertriglyceridemia very high (>500 mg/dL)

• Pregnancy

• Systolic blood pressure > 180 mmHg or Diastolic blood pressure >105 mmHg (patients could be re-screened after blood pressure control)

• 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 syndrom, Thyrotoxicosis.