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

NCT02145611 | Completed Phase 4

• 1 other identifier: CLAF237ABR07T
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Hypertension; Endothelial Dysfunction

Keywords

hypertension, diabetes, endothelial function

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the reactive hyperemia index (RHI) after 12 weeks of vildagliptin x glibenclamide treatment

  12 weeks

• Change from baseline in the central blood pressure after 12 weeks of vildagliptin x glibenclamide treatment

  12 weeks

Study Arms (2)

vildagliptin

ACTIVE COMPARATOR

Vildagliptin: Dosage: 100 mg/day; Duration: 12 weeks

Drug: Vildagliptin

glibenclamide

ACTIVE COMPARATOR

Glibenclamide: Dosage: 5 mg to 20 mg; Duration: 12 weeks

Drug: Glibenclamide

Interventions

Glibenclamide DRUG

Glibenclamide

Also known as: Daonil

glibenclamide

Vildagliptin DRUG

Vildagliptin

Also known as: Galvus

vildagliptin

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 35 years;
• history of type 2 diabetes mellitus and mild hypertension (blood pressure \<160 x 100 mmHg) for a shorter period of time as 15 years;
• body mass index \< 35 Kg/m2;
• plasma concentration of glycated hemoglobin between 7.0 and 10.5% -

You may not qualify if:

• smoking in the last 6 months;
• gestation;
• breast-feeding;
• creatinine clearance \< 45 ml / min / m2 (MDRD);
• using any type of insulin, pioglitazone, receptor agonist GLP-1, dipeptidyl peptidase (DPP-4) inhibitor or acarbose;
• serum alanine aminotransferase or aspartate aminotransferase three times the upper limit of the method;
• individuals with cancer, heart failure functional class II, III and IV, ischemic heart disease, or cerebrovascular atherosclerotic;
• 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;
• individuals using 3 or more antihypertensive drugs, characterizing resistant hypertension;
• intolerance to metformin;
• individuals unable to give informed consent. -

Sponsors & Collaborators

• Dr. José Fernando Vilela-Martin MD PhD: lead
• Novartis: collaborator

Study Sites (1)

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Related Publications (2)

• Cosenso-Martin LN, Giollo-Junior LT, Fernandes LAB, Cesarino CB, Nakazone MA, Machado MN, Yugar-Toledo JC, Vilela-Martin JF. Effect of vildagliptin versus glibenclamide on endothelial function and arterial stiffness in patients with type 2 diabetes and hypertension: a randomized controlled trial. Acta Diabetol. 2018 Dec;55(12):1237-1245. doi: 10.1007/s00592-018-1204-1. Epub 2018 Aug 9.

  PMID: 30094725 DERIVED

• Cosenso-Martin LN, Giollo-Junior LT, Martineli DD, Cesarino CB, Nakazone MA, Cipullo JP, Vilela-Martin JF. Twelve-week randomized study to compare the effect of vildagliptin vs. glibenclamide both added-on to metformin on endothelium function in patients with type 2 diabetes and hypertension. Diabetol Metab Syndr. 2015 Aug 26;7:70. doi: 10.1186/s13098-015-0062-z. eCollection 2015.

  PMID: 26312070 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Diabetes Mellitus

Interventions

Glyburide; Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jose F Vilela-Martin, MD PhD

  Fundação Faculdade Regional de Medicina de São José do Rio Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician Doctor

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: May 23, 2014
• Study Start: July 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

BR (1)