Type 2 DiabetesNCT06068686
Vildagliptin Versus Glimepiride in Type 2 Diabetic Patients
A study testing Vildagliptin 50 MG and Glimepiride 3 Mg Oral Tablet in people with Type 2 Diabetes, run by Damanhour University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vildagliptin 50 MG and Glimepiride 3 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 70 uncontrolled adult patients with Type II-diabetes mellitus
Who cannot join
- Hepatic impairment.
- Active malignancy.
- Planned surgical intervention.
- Any signs of hypersensitivity or contraindication to study drugs developed.
- Addition of any anti-diabetic medications or insulin during follows up.
- Chronic inflammatory disease (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
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- Pregnancy, lactation or child-bearing potential.
- Cardiac disease.
- Renal impairment.
- History of T1DM, SIAD, or diabetes insipidus.
- Therapy with any diuretic or a medication affecting the RAAS.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
Damanhūr, Elbehairah, 31527
About this study
Official title: Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients
The aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers.
Read the detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
- Serum samples will be collected for measuring the biomarkers.
- All enrolled patients will be divided into two groups; both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
- All patients will be followed up during 12 week period.
- At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
- Results, conclusion, discussion and recommendations will be given. Methodology
- Copeptin and NT-proBNP will be determined by ELISA.
- Lipid profile will be measured.
- Fasting blood glucose and Insulin will be measured and HOMA-IR will be calculated for all subjects.
- Body weight and blood pressure will be measured.
- HbA1C will be measured.
- Conditions
- Type 2 Diabetes
- Being tested
- Vildagliptin 50 MG, Glimepiride 3 Mg Oral Tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin 50 MGDrug
Also called Vildagliptin
vildagliptin plus their metformin.
Glimepiride 3 Mg Oral TabletDrug
Also called Amaryl
glimepiride plus their metformin
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Group I (N=35) are patients who the endocrinologist prescribed them Vildagliptin 50mg /tab plus their Metformin 500mg /tab once daily for 12 weeks to control their blood sugar level. Receives: Drug: Vildagliptin 50 MG |
| Glimepiride | Active comparator | Group II (N=35) are patients who the endocrinologist prescribed them Glimepiride 3mg / tab plus Metformin 500mg /tab once daily for 12 weeks. Receives: Drug: Glimepiride 3 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Copeptin Concentration (pg/ml)
Copeptin serum Level
Measured: 3 month
NT-proBNP Concentration (pg/ml)
NT-proBNP serum Level
Measured: 3 Months
Secondary outcomes (1)
Fasting blood glucose (mg/dl)
Fasting Blood Glucose level
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Oct 2022
- Primary completion30 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 70 enrolled patients will be divided into two groups (35 each); both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068686
- Sponsor's protocol ID
- Vilda. vs Glim. in T2D
- Status last verified
- Feb 2025
- First submitted
- 29 Sep 2023
- Last updated
- 4 Feb 2025
- 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vildagliptin Versus Glimepiride on Copeptin and Fetuin-A in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT06068686
- Acronym / sponsor ID
- Vilda. vs Glim. in T2D
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Oct 2023 (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.
The aim of this study is to evaluate the effect of vildagliptin on copeptin in comparison to glimepiride, and whether copeptin could be used as a marker for the efficacy of vildagliptin in type 2 diabetes mellitus patients, and how copeptin correlates with other diabetic and cardiac markers.
Detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants agreed to take part in this clinical study and provide informed consent.
- Patients with uncontrolled DM type 2 who are on metformin will be enrolled from endocrinology clinic at Damanhour general hospital.
- Serum samples will be collected for measuring the biomarkers.
- All enrolled patients will be divided into two groups; both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
- All patients will be followed up during 12 week period.
- At the end of the 12 week period, serum samples will be recollected for measuring the biomarkers after treatment.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 12 weeks.
- Results, conclusion, discussion and recommendations will be given. Methodology
- Copeptin and NT-proBNP will be determined by ELISA.
- Lipid profile will be measured.
- Fasting blood glucose and Insulin will be measured and HOMA-IR will be calculated for all subjects.
- Body weight and blood pressure will be measured.
- HbA1C will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 70 enrolled patients will be divided into two groups (35 each); both groups will be patients who are uncontrolled and already on metformin, group I will receive vildagliptin as an add-on therapy while group II will receive glimepiride.
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: Vildagliptin 50 MGGroup I (N=35) are patients who the endocrinologist prescribed them Vildagliptin 50mg /tab plus their Metformin 500mg /tab once daily for 12 weeks to control their blood sugar level. |
| Glimepiride | Active comparator | Drug: Glimepiride 3 Mg Oral TabletGroup II (N=35) are patients who the endocrinologist prescribed them Glimepiride 3mg / tab plus Metformin 500mg /tab once daily for 12 weeks. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 70 uncontrolled adult patients with Type II-diabetes mellitus
Key exclusion criteria (11 listed)
- Hepatic impairment.
- Active malignancy.
- Planned surgical intervention.
- Any signs of hypersensitivity or contraindication to study drugs developed.
- Addition of any anti-diabetic medications or insulin during follows up.
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 |
|---|---|---|
| Vildagliptin 50 MGAlso: Vildagliptinvildagliptin plus their metformin. | Drug | Vildagliptin |
| Glimepiride 3 Mg Oral TabletAlso: Amarylglimepiride plus their metformin | Drug | Glimepiride |
Primary outcome
Copeptin Concentration (pg/ml)
Time frame: 3 month
Copeptin serum Level
NT-proBNP Concentration (pg/ml)
Time frame: 3 Months
NT-proBNP serum Level
1 secondary outcome
Fasting blood glucose (mg/dl)
Time frame: 3 month
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 4 Feb 2025.
- 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.
Rehab H Werida, Ass Prof. study chair
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vildagliptin 50 MG and Glimepiride 3 Mg Oral Tablet in people with Type 2 Diabetes, run by Damanhour 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 11 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 4 Feb 2025. 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.
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?
Copeptin Concentration (pg/ml) (time frame: 3 month). 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 4 Feb 2025.