Reducing the Elevated Blood Pressure for Diabetic Hypertensive PatientsPhase 4NCT03253562
Metformin Versus Vildagliptin for Diabetic Hypertensive Patients
A Phase 4 study testing Metformin Pill and Vildagliptin 50 mg in people with Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients, run by MTI University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients
- What is being tested?
- Metformin Pill and Vildagliptin 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2017to 1 Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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..
- Being tested
- Metformin Pill, Vildagliptin 50 mg
- Keywords
- diabetes, Metformin, vildagliptin, hypertension, cardiovascular risk
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin PillDrug
a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus
Vildagliptin 50 mgDrug
Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Metformin Pill |
| Vildagliptin treated group | Other | diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes Receives: Drug: Vildagliptin 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
benefit of reducing hypertension in diabetic hypertensive patients
blood pressure will be measured
Measured: 6 months
benefit of lowering cardiovascular risks for diabetic hypertensive patients
total lipid profile will be measured
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
Measured: 6 months
Secondary outcomes (2)
reducing obesity for diabetic patients
difference in body weight at the beginning and the end of the study will be measured
Measured: 6months
comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients
glycated hemoglobin will be measured
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Feb 2017
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reducing the Elevated Blood Pressure for Diabetic Hypertensive PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Kamal Zaafar Ali, MTI University
- Investigators
- Hekma A Abdel-Latif, Professor, Study chair, cairo university faculty of pharmacyAbdel Rahman M El-Naggar, Professor, Study director, Cairo UniversityMohammed F Elyamany, assistant professor, Study director, cairo university faculty of pharmacySoha O Hassanin, lecturer, Study director, MTI unuversity faculty of pharmacyAtef Bassyouni, Professor, Study director, National institute of diabetes and endocrinologyDalia K Zaafar, assistant lecturer, Principal investigator, MTI unuversity faculty of pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253562
- Sponsor's protocol ID
- IDE00217
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Vildagliptin Versus Metformin in Reduction of Cardiovascular Complications in Type 2 Diabetic Patients With Hypertension
- ClinicalTrials.gov ID
- NCT03253562
- Acronym / sponsor ID
- IDE00217
- Keywords
- diabetes, Metformin, vildagliptin, hypertension, cardiovascular risk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Metformin Pilldiabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes |
| Vildagliptin treated group | Other | Drug: Vildagliptin 50 mgdiabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Pilla biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus | Drug | Metformin treated group |
| Vildagliptin 50 mgDpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus | Drug | Vildagliptin treated group |
Primary outcome
benefit of reducing hypertension in diabetic hypertensive patients
Time frame: 6 months
blood pressure will be measured
benefit of lowering cardiovascular risks for diabetic hypertensive patients
Time frame: 6 months
total lipid profile will be measured
benefit of improving the condition of elevated blood pressure in patients through neovascularization
Time frame: 6 months
vascular endothelial growth factor level in serum will be measured
2 secondary outcomes
reducing obesity for diabetic patients
Time frame: 6months
comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients
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Type 2 Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hekma A Abdel-Latif, Professor study chair
cairo university faculty of pharmacy
Abdel Rahman M El-Naggar, Professor study director
Cairo University
Mohammed F Elyamany, assistant professor study director
cairo university faculty of pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Pill and Vildagliptin 50 mg in people with Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
benefit of reducing hypertension in diabetic hypertensive patients (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.