NCT03253562

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

August 10, 2017

Last Update Submit

August 15, 2017

Conditions

Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Keywords

diabetesMetforminvildagliptinhypertensioncardiovascular risk

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • reducing obesity for diabetic patients

    6months

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

    6 months

Study Arms (4)

Healthy control

NO INTERVENTION

healthy volunteers not suffering from diabetes or hypertension

diabetic hypertensive recently diagnosed patients

NO INTERVENTION

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

Metformin treated group

OTHER

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

Drug: Metformin Pill

Vildagliptin treated group

OTHER

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

Drug: Vildagliptin 50 mg

Interventions

Metformin PillDRUG

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

Metformin treated group
Vildagliptin 50 mgDRUG

Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

Vildagliptin treated group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institute of diabetes and endocrinology

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Diabetes MellitusHypertension

Interventions

MetforminVildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsNitrilesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hekma A Abdel-Latif, Professor

    cairo university faculty of pharmacy

    STUDY CHAIR

  • 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

    STUDY DIRECTOR

  • Dalia K Zaafar, assistant lecturer

    MTI unuversity faculty of pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of pharmacology and toxicology

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 18, 2017

Study Start

February 1, 2017

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)