Diabetes Mellitus, Type 2Phase 4NCT04916093
Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes
A Phase 4 study testing Vildagliptin 50 MG, Sitagliptin 100mg and MetFORMIN 1000 Mg Oral Tablet in people with Diabetes Mellitus, Type 2, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin 50 MG, Sitagliptin 100mg and MetFORMIN 1000 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2019to 15 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.
Who cannot join
- Type1 diabetes or ketoacidosis
- End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
- Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
- Any stage of heart failure
- Previous history of pancreatitis
- Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes
The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.
Read the detailed description
This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin 50 MG, Sitagliptin 100mg, MetFORMIN 1000 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
Galvus 50 mg oral tablets
Sitagliptin 100mgDrug
Januvia 100mg oral tablets
MetFORMIN 1000 Mg Oral TabletDrug
Glucophage 1000 mg oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin Group | Experimental | Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast. Receives: Drug: Sitagliptin 100mg |
| Vildagliptin Group | Experimental | Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper. Receives: Drug: Vildagliptin 50 MG |
| Metformin Group | Active comparator | Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily Receives: Drug: MetFORMIN 1000 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycemic parameters
serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)
Measured: 3-months
Changes in Serum insulin (IU/l)
using enzyme immunoassay (EIA) kits
Measured: 3-months
Insulin resistance
measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405
Measured: 3-months
Beta cell function (HOMA-B)
measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)
Measured: 3-months
Changes in HbA1c (%)
Changes in HbA1c (%)
Measured: 3-months
Secondary outcomes (3)
Changes in Lipid profile
(total cholesterol, TG, HDL, and LDL) (mg/dl)
Measured: 3-months
Changes in liver enzymes
ALT and AST (U/l)
Measured: 3-months
Changes in Renal function tests
creatinine and urea (mg/dl)
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start20 Dec 2019
- Primary completion10 Jun 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University
- Responsible party
- Principal investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
- Investigators
- Asmaa A Elsayed, Master, Principal investigator, BUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916093
- Sponsor's protocol ID
- MinyaU
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04916093
- Acronym / sponsor ID
- MinyaU
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Minia University
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 7 Jun 2021 (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 current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.
Detailed description
This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin Group | Experimental | Drug: Sitagliptin 100mgIncluded 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast. |
| Vildagliptin Group | Experimental | Drug: Vildagliptin 50 MGIncluded 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper. |
| Metformin Group | Active comparator | Drug: MetFORMIN 1000 Mg Oral TabletIncluded 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.
Key exclusion criteria (7 listed)
- Type1 diabetes or ketoacidosis
- End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
- Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
- Any stage of heart failure
- Previous history of pancreatitis
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 MGGalvus 50 mg oral tablets | Drug | Vildagliptin Group |
| Sitagliptin 100mgJanuvia 100mg oral tablets | Drug | Sitagliptin Group |
| MetFORMIN 1000 Mg Oral TabletGlucophage 1000 mg oral tablets | Drug | Metformin Group |
Primary outcome
Changes in glycemic parameters
Time frame: 3-months
serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)
Changes in Serum insulin (IU/l)
Time frame: 3-months
using enzyme immunoassay (EIA) kits
Insulin resistance
Time frame: 3-months
measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405
Beta cell function (HOMA-B)
Time frame: 3-months
measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)
Changes in HbA1c (%)
Time frame: 3-months
Changes in HbA1c (%)
3 secondary outcomes
Changes in Lipid profile
Time frame: 3-months
Changes in liver enzymes
Time frame: 3-months
Changes in Renal function tests
Time frame: 3-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 7 Jun 2021.
- 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.
Asmaa A Elsayed, Master principal investigator
BUC
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 50 MG, Sitagliptin 100mg and MetFORMIN 1000 Mg Oral Tablet in people with Diabetes Mellitus, Type 2, run by Beni-Suef 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 7 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 7 Jun 2021. 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?
Changes in glycemic parameters (time frame: 3-months). The study lists 5 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 7 Jun 2021.