Skip to main content
OpenTrials
Completed

NCT Number: NCT03253562

Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

This is a controlled study to measure the efficacy of using metformin or vildagliptin for type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk resulting from both diabetes and hypertension using different parameters measuring

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

National institute of diabetes and endocrinology

Cairo, 11311, Egypt

About this study

Several studies indicated that type 2 diabetes mellitus and hypertension are associated with increased cardiovascular complications. Recently, studies suggest that metformin and vildagliptin can reduce cardiovascular complications in diabetic patients with unclear mechanisms. This work aimed to determine the effect of metformin and vildagliptin on diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy volunteers, groupII: patients recently diagnosed with their hypertension and diabetes, groupIII: patients treated with captopril (25mg once daily) for their hypertension in addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period, then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial growth factor (VEGF) levels in serum will be measured for different groups to estimate the benefits of one drug over the other one in protecting against cardiovascular risks for diabetic hypertensive patients..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suffering from moderate HTN and DM, their HbA1c ≥ 7 and age range between 40-60 years, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission

Exclusion criteria

  • Clinical evidence of ischemic heart disease, chronic obstructive pulmonary disease, presence of diabetic ketoacidosis (DKA), patients admitted to intensive care unit (ICU), subjects expected to undergo surgery during the study period, patients with clinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0 mg/dL), systemic infections or pregnancy. Also, patients on medications known to interfere with the blood glucose level (either increasing or decreasing) were excluded from the study.

Treatment and study plan

Metformin Pill

Drug

a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus

Vildagliptin 50 mg

Drug

Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

Primary outcomes

  1. benefit of reducing hypertension in diabetic hypertensive patients

    Time frame: 6 months

    blood pressure will be measured

  2. benefit of lowering cardiovascular risks for diabetic hypertensive patients

    Time frame: 6 months

    total lipid profile will be measured

  3. benefit of improving the condition of elevated blood pressure in patients through neovascularization

    Time frame: 6 months

    vascular endothelial growth factor level in serum will be measured

Secondary outcomes

  1. reducing obesity for diabetic patients

    Time frame: 6months

    difference in body weight at the beginning and the end of the study will be measured

  2. comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients

    Time frame: 6 months

    glycated hemoglobin will be measured

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

Comparative Efficacy and Safety of Vildagliptin Versus Metformin in Reduction of Cardiovascular Complications in Type 2 Diabetic Patients With Hypertension

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.