Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

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

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

Study Overview

• Status: Completed
• Conditions: Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients
• Intervention / Treatment: Drug: Metformin Pill; Drug: Vildagliptin 50 mg

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..

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11311
    • National Institute of Diabetes and Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy control; healthy volunteers not suffering from diabetes or hypertension
No Intervention: diabetic hypertensive recently diagnosed patients; recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet
Other: Metformin treated group; diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes	Drug: Metformin Pill; a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus
Other: Vildagliptin treated group; diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes	Drug: Vildagliptin 50 mg; Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
benefit of reducing hypertension in diabetic hypertensive patients	blood pressure will be measured	6 months
benefit of lowering cardiovascular risks for diabetic hypertensive patients	total lipid profile will be measured	6 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
reducing obesity for diabetic patients	difference in body weight at the beginning and the end of the study will be measured	6months
comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients	glycated hemoglobin will be measured	6 months

Collaborators and Investigators

• Sponsor: MTI University
• Investigators: Study Chair: Hekma A Abdel-Latif, Professor, cairo university faculty of pharmacy; Study Director: Abdel Rahman M El-Naggar, Professor, Cairo University; Study Director: Mohammed F Elyamany, assistant professor, cairo university faculty of pharmacy; Study Director: Soha O Hassanin, lecturer, MTI unuversity faculty of pharmacy; Study Director: Atef Bassyouni, Professor, National Institute of Diabetes and Endocrinology; Principal Investigator: Dalia K Zaafar, assistant lecturer, MTI unuversity faculty of pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: diabetes; Metformin; hypertension; cardiovascular risk; vildagliptin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Vildagliptin
• Other Study ID Numbers: IDE00217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No