Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

MTI University

Status and phase: Completed; Phase 4

Conditions: Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Treatments: Drug: Metformin Pill; Drug: Vildagliptin 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03253562

IDE00217

Details and patient eligibility

About

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

Full 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..

Enrollment: 120 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Healthy control

No Intervention group

Description:

healthy volunteers not suffering from diabetes or hypertension

diabetic hypertensive recently diagnosed patients

No Intervention group

Description:

recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet

Metformin treated group

Other group

Description:

diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes

Treatment:

Drug: Metformin Pill

Vildagliptin treated group

Other group

Description:

diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes

Treatment:

Drug: Vildagliptin 50 mg