Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253562
• Other study ID #: IDE00217
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2017
• Last updated: August 15, 2017
• Start date: February 1, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Intervention

Drug:
• Metformin Pill
a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus
• Vildagliptin 50 mg
Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

Locations

Country	Name	City	State
Egypt	National institute of diabetes and endocrinology	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	benefit of reducing hypertension in diabetic hypertensive patients	blood pressure will be measured	6 months
Primary	benefit of lowering cardiovascular risks for diabetic hypertensive patients	total lipid profile will be measured	6 months
Primary	benefit of improving the condition of elevated blood pressure in patients through neovascularization	vascular endothelial growth factor level in serum will be measured	6 months
Secondary	reducing obesity for diabetic patients	difference in body weight at the beginning and the end of the study will be measured	6months
Secondary	comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients	glycated hemoglobin will be measured	6 months