Metabolic SyndromePhase 4NCT04485845
Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression
A Phase 4 study testing Vildagliptin, Captopril Tablets and MetFORMIN 500 Mg Oral Tablet in people with Metabolic Syndrome and Diabete Type 2, run by Cairo University at 1 site in Egypt.
Trial summary
Several crosssectional and prospective studies have shown that metabolic syndrome and its related components are associated with both prevalent and incident CKD . Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin remain unclear, they extend well beyond glycemic lowering, and… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Diabete Type 2, Kidney Insufficiency
- What is being tested?
- Vildagliptin, Captopril Tablets and MetFORMIN 500 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 30 Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women 40-70 years of age
- body mass index be-tween≥22 and ≤40 kg/m2.
- DM with an HbA1c ≥ 7
Who cannot join
- pregnant or nursing women; (2) chronic (>7 consecutive days) oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history or evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase activities > 2.5 times the upper limit of normal) (4) ischemic heart disease or cerebrovascular disease (5) creatinine level > 0.133 mmol/L (6) major diabetes complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7) extreme dyslipidemia, such as familial hypercholesterolaemia
- -
Trial locations and contacts
1 site in 1 country.
soha hassanin, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
National Diabetes & Endocrinology Institute
Cairo, 11311
dalia zaafar, phd
soha hassanin, phd
About this study
Official title: Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression
Several crosssectional and prospective studies have shown that metabolic syndrome and its related components are associated with both prevalent and incident CKD .
Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin remain unclear, they extend well beyond glycemic lowering, and therefore are probably best considered diverse "cardiometabolic" pharmaceuticals rather than simply type 2 diabetes drugs.
Metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs on drug-naïve diabetic patients during 24 week use warrants investigation. The investigator's purpose was to observe their effects on weight control, Cardiometabolic Risk Factors, Metabolic Syndrome risk, and diabetic nephrooathy Progression.
Read the detailed description
the current study is investigating the relation betweeneach componant of metabolic syndrome and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney protective effect of metformin and vildagliptin and the mechanism of this action whether it is related to their glucose lowering mechanism or not is also one of the important points to be investigated in the study
- Conditions
- Metabolic Syndrome, Diabete Type 2, Kidney Insufficiency
- Being tested
- Vildagliptin, Captopril Tablets, MetFORMIN 500 Mg Oral Tablet
- Keywords
- metfomin, vildagliptin, metabolic syndrome, T2DM, nephropathy
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors
Captopril TabletsDrug
used to treat hypertension in metabolic syndrome patients and as a renal protector
MetFORMIN 500 Mg Oral TabletDrug
antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome
| Study group | Role | What they receive |
|---|---|---|
| metformin treated group | Active comparator | A group of patients treated with a daily dose of metformin Receives: Drug: Captopril Tablets; Drug: MetFORMIN 500 Mg Oral Tablet |
| vildagliptin treated group | Experimental | A group of patients treated with a daily dose of vildagliptin Receives: Drug: Vildagliptin; Drug: Captopril Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of metabolic syndrome complications
investigate the effect of antidiabetic drugs on improving patients' cases and reduce complcations of metablic syndrome and that will be assessed by measuring glucose serum levels, insulin plasma levels to calculate insulin resistance by HOMA-ir
Measured: 24 weeks
estimation of metabolic syndrome deterioration
study the effect of both antidiabetic drugs on blood pressure
Measured: 24 weeks
Secondary outcomes (1)
reduce nephropathic impairement
study the impact of both metformin and vildagliptin on reducing kidney deterioration for patients suffering from metabolic syndrome and that can be assessed by measuring kidney function serologically using ELISA kits for each parameter
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Nov 2019
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia K. Zaafar, Cairo University
- Investigators
- Dalia Zaafar, PhD, Principal investigator, Lecturer of clinical pharmacology and toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485845
- Sponsor's protocol ID
- IDE00218
- Status last verified
- Jul 2020
- First submitted
- 24 Mar 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression
- ClinicalTrials.gov ID
- NCT04485845
- Acronym / sponsor ID
- IDE00218
- Conditions
- Metabolic Syndrome, Diabete Type 2, Kidney Insufficiency
- Keywords
- metfomin, vildagliptin, metabolic syndrome, T2DM, nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 24 Jul 2020 (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.
Several crosssectional and prospective studies have shown that metabolic syndrome and its related components are associated with both prevalent and incident CKD .
Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin remain unclear, they extend well beyond glycemic lowering, and therefore are probably best considered diverse "cardiometabolic" pharmaceuticals rather than simply type 2 diabetes drugs.
Metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs on drug-naïve diabetic patients during 24 week use warrants investigation. The investigator's purpose was to observe their effects on weight control, Cardiometabolic Risk Factors, Metabolic Syndrome risk, and diabetic nephrooathy Progression.
Detailed description
the current study is investigating the relation betweeneach componant of metabolic syndrome and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney protective effect of metformin and vildagliptin and the mechanism of this action whether it is related to their glucose lowering mechanism or not is also one of the important points to be investigated in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin treated group | Active comparator | Drug: Captopril Tablets, Drug: MetFORMIN 500 Mg Oral TabletA group of patients treated with a daily dose of metformin |
| vildagliptin treated group | Experimental | Drug: Vildagliptin, Drug: Captopril TabletsA group of patients treated with a daily dose of vildagliptin |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men or women 40-70 years of age
- body mass index be-tween≥22 and ≤40 kg/m2.
- DM with an HbA1c ≥ 7
Key exclusion criteria (2 listed)
- pregnant or nursing women; (2) chronic (>7 consecutive days) oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history or evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase activities > 2.5 times the upper limit of normal) (4) ischemic heart disease or cerebrovascular disease (5) creatinine level > 0.133 mmol/L (6) major diabetes complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7) extreme dyslipidemia, such as familial hypercholesterolaemia
- -
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 |
|---|---|---|
| Vildagliptinto compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors | Drug | vildagliptin treated group |
| Captopril Tabletsused to treat hypertension in metabolic syndrome patients and as a renal protector | Drug | metformin treated group, vildagliptin treated group |
| MetFORMIN 500 Mg Oral Tabletantihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome | Drug | metformin treated group |
Primary outcome
progression of metabolic syndrome complications
Time frame: 24 weeks
investigate the effect of antidiabetic drugs on improving patients' cases and reduce complcations of metablic syndrome and that will be assessed by measuring glucose serum levels, insulin plasma levels to calculate insulin resistance by HOMA-ir
estimation of metabolic syndrome deterioration
Time frame: 24 weeks
study the effect of both antidiabetic drugs on blood pressure
1 secondary outcome
reduce nephropathic impairement
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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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.
soha hassanin, PhD contact
Dalia Zaafar, PhD principal investigator
Lecturer of clinical pharmacology and toxicology
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 Vildagliptin, Captopril Tablets and MetFORMIN 500 Mg Oral Tablet in people with Metabolic Syndrome and Diabete Type 2, run by Cairo 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Zaafar, PhD (00201117922833, dalia.zaffar@pharm.mti.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of metabolic syndrome complications (time frame: 24 weeks). The study lists 2 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 24 Jul 2020.