Vildagliptin vs. Glibenclamide in Endothelial Function in Type 2 Diabetes and Hypertension

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Cardiovascular disease is a major public health problem in our country. Among the causes of cardiovascular diseases are High Blood Pressure (HBP) and Diabetes Mellitus (DM). Type 2 diabetes (DM2) is associated with a twofold risk of cardiovascular disease, and endothelial dysfunction is an early marker of vascular complications. There is evidence of action of glucagon-like peptide 1 (GLP-1) on endothelial cells and vascular smooth muscle. Vildagliptin is a drug used in the treatment of DM2 able to prolong the activity of GLP-1, improving glycemic control and endothelial function.

Objectives: To evaluate the effect of vildagliptin on endothelial function in patients with DM2 and hypertension using the Endo-PAT 2000 device.

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

Details

• Lead Sponsor: Dr. José Fernando Vilela-Martin MD PhD
• Collaborator: Novartis
• Treatments: Glyburide; Vildagliptin

Criteria

Inclusion Criteria:

1. older than 35 years;

2. history of type 2 diabetes mellitus and mild hypertension (blood pressure <160 x 100 mmHg) for a shorter period of time as 15 years;

3. body mass index < 35 Kg/m2;

4. plasma concentration of glycated hemoglobin between 7.0 and 10.5% -

Exclusion Criteria:

1. smoking in the last 6 months;

2. gestation;

3. breast-feeding;

4. creatinine clearance < 45 ml / min / m2 (MDRD);

5. using any type of insulin, pioglitazone, receptor agonist GLP-1, dipeptidyl peptidase (DPP-4) inhibitor or acarbose;

6. serum alanine aminotransferase or aspartate aminotransferase three times the upper limit of the method;

7. individuals with cancer, heart failure functional class II, III and IV, ischemic heart disease, or cerebrovascular atherosclerotic;

8. individuals with positive exercise test for coronary disease, characterized by ST-segment depression ≥ 1 mm, horizontal or downward and duration of 0.08 seconds after the J point or typical chest pain during the test;

9. individuals using 3 or more antihypertensive drugs, characterizing resistant hypertension;

10. intolerance to metformin;

11. individuals unable to give informed consent. -