Clinical trial NCT03253562: Metformin Versus Vildagliptin for Diabetic Hypertensive Patients
Official title: Comparative Efficacy and Safety of Vildagliptin Versus Metformin in Reduction of Cardiovascular Complications in Type 2 Diabetic Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients
Keywords: diabetes
Metformin
vildagliptin
hypertension
cardiovascular risk
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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..

Eligibility criteria: 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.

Primary outcomes:
measure: benefit of reducing hypertension in diabetic hypertensive patients
timeFrame: 6 months
measure: benefit of lowering cardiovascular risks for diabetic hypertensive patients
timeFrame: 6 months
measure: benefit of improving the condition of elevated blood pressure in patients through neovascularization
timeFrame: 6 months
Secondary outcomes:
measure: reducing obesity for diabetic patients
timeFrame: 6months
measure: comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National institute of diabetes and endocrinology
Study officials:
affiliation: cairo university faculty of pharmacy
name: Hekma A Abdel-Latif, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Abdel Rahman M El-Naggar, Professor
role: STUDY_DIRECTOR
affiliation: cairo university faculty of pharmacy
name: Mohammed F Elyamany, assistant professor
role: STUDY_DIRECTOR
affiliation: MTI unuversity faculty of pharmacy
name: Soha O Hassanin, lecturer
role: STUDY_DIRECTOR
affiliation: National institute of diabetes and endocrinology
name: Atef Bassyouni, Professor
role: STUDY_DIRECTOR
affiliation: MTI unuversity faculty of pharmacy
name: Dalia K Zaafar, assistant lecturer
role: PRINCIPAL_INVESTIGATOR
References: