Diabetes Mellitus, Type 2NCT04240171
Dapagliflozin Versus Glimepiride Effect in Patient With Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2, run by Damanhour University at 1 site in Egypt.
Trial summary
Research objectives: The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin 5Mg Tab and Glimepiride 4Mg Tab
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 31 Jan 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3- 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride * All patients will be followed up during 3 months' period. * At the end of 3 months, step 4 will be repeated.
Who may be able to join
- 60 Patients with type 2 DM diagnosed clinically. The age ranged from 18 to 70 years. There are no limits to the duration of DM and gender.
- HbA1c ≥ 7
Who cannot join
- Other types of DM
- Hypersensitivity to the drug
- Abnormal liver function
- Patients with renal impairment (eGFR ≤ 60 ml/min)
- Previous history of bladder cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Dapagliflozin Versus Glimepiride Effect on Insulin Regulated Aminopeptidase (IRAP) and Interleukin-34 (IL-34) in Patient With Type 2 Diabetes Mellitus
Research objectives:
The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.
Read the detailed description
Method and proposal steps:
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participant agreed to take part in this clinical study and provide informed consent.
- 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital.
- Serum samples will be collected for measuring the biomarkers.
- All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride
- All patients will be followed up during 3 months' period.
- At the end of 3 months, step 4 will be repeated.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcomes: the primary outcome is the change from baseline to post-treatment insulin sensitivity reflected by change of serum level of measured marker after 3 months.
- Results, discussion, conclusion, and recommendations will be given.
Methodology:
- Fasting blood glucose (FBG) 2 hrs. post prandial blood glucose(2hPPBG) will be measured by glucometer.
- HbA1c %, Fasting plasma insulin (FPI), Interleukin-34 (IL-34), NT-Pro BNP and extracellular domain of insulin regulated aminopeptidase (IRAPe) will be assayed by Enzyme-Linked Immunosorbent Assay (ELISA).
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin 5Mg Tab, Glimepiride 4Mg Tab
- 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.
Dapagliflozin 5Mg TabDrug
Also called Diglifloz
Dapagliflozin 5mg tablets daily
Glimepiride 4Mg TabDrug
Also called Amaryl
Glimepiride Tablets daily
| Study group | Role | What they receive |
|---|---|---|
| dapagliflozin | Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Receives: Drug: Dapagliflozin 5Mg Tab | |
| glimepiride | Group 2 (n=30): are the patients who are prescribed glimepiride Receives: Drug: Glimepiride 4Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugar (mg/dl)
serum blood glucose
Measured: three months
HbA1c %
Glycated Hemoglobin
Measured: three months
Secondary outcomes (3)
NT-Pro BNP (ng/ml)
Natriuretic peptide tests measure levels of BNP or NT-proBNP in the blood.
Measured: Three Months
IRAPe (ng/ml)
extracellular part of insulin-regulated aminopeptidase (IRAPe).
Measured: Three Months
IL-34 (pg./ml)
interleukin (IL)-34.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Dec 2020
- Primary completion30 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Nashwa EL-Gharabawy, Lecturer, Study chair, Tanta UniversityRehab Werida, Study director, Damanhour University, Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240171
- Sponsor's protocol ID
- Dapagliflozin in T2DM
- Status last verified
- Apr 2023
- First submitted
- 15 Sep 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monami M, Nardini C, Mannucci E. Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2014 May;16(5):457-66. doi: 10.1111/dom.12244. Epub 2013 Dec 29.
PubMed 24320621Abdul-Ghani MA, Norton L, DeFronzo RA. Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus. Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F889-900. doi: 10.1152/ajprenal.00267.2015. Epub 2015 Sep 9.
PubMed 26354881Davidson JA, Kuritzky L. Sodium glucose co-transporter 2 inhibitors and their mechanism for improving glycemia in patients with type 2 diabetes. Postgrad Med. 2014 Oct;126(6):33-48. doi: 10.3810/pgm.2014.10.2819.
PubMed 25414933Zekry R, Omran GA, El-Gharbawy NM, Werida RH. Comparative study of Dapagliflozin versus Glimepiride effect on insulin regulated aminopeptidase (IRAP) and interleukin-34 (IL-34) in patient with type 2 diabetes mellitus. Sci Rep. 2023 Apr 18;13(1):6302. doi: 10.1038/s41598-023-33417-3.
PubMed 37072577
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Dapagliflozin Versus Glimepiride Effect on Insulin Regulated Aminopeptidase (IRAP) and Interleukin-34 (IL-34) in Patient With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04240171
- Acronym / sponsor ID
- Dapagliflozin in T2DM
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 27 Jan 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.
Research objectives:
The aim of the study to check the effect of Dapagliflozin versus Glimepiride on insulin regulated aminopeptidase (IRAPe), NT-Pro BNP and interleukin-34 (IL-34) in patients with type 2 diabetes mellitus, and associated it with insulin resistance.
Detailed description
Method and proposal steps:
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participant agreed to take part in this clinical study and provide informed consent.
- 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital.
- Serum samples will be collected for measuring the biomarkers.
- All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride
- All patients will be followed up during 3 months' period.
- At the end of 3 months, step 4 will be repeated.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcomes: the primary outcome is the change from baseline to post-treatment insulin sensitivity reflected by change of serum level of measured marker after 3 months.
- Results, discussion, conclusion, and recommendations will be given.
Methodology:
- Fasting blood glucose (FBG) 2 hrs. post prandial blood glucose(2hPPBG) will be measured by glucometer.
- HbA1c %, Fasting plasma insulin (FPI), Interleukin-34 (IL-34), NT-Pro BNP and extracellular domain of insulin regulated aminopeptidase (IRAPe) will be assayed by Enzyme-Linked Immunosorbent Assay (ELISA).
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dapagliflozin | – | Drug: Dapagliflozin 5Mg TabGroup 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. |
| glimepiride | – | Drug: Glimepiride 4Mg TabGroup 2 (n=30): are the patients who are prescribed glimepiride |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3- 60 Patients with type 2 DM will be enrolled Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who are prescribed dapagliflozin to control their blood sugar level. Group 2 (n=30): are the patients who are prescribed glimepiride * All patients will be followed up during 3 months' period. * At the end of 3 months, step 4 will be repeated.
Key inclusion criteria (2 listed)
- 60 Patients with type 2 DM diagnosed clinically. The age ranged from 18 to 70 years. There are no limits to the duration of DM and gender.
- HbA1c ≥ 7
Key exclusion criteria (5 listed)
- Other types of DM
- Hypersensitivity to the drug
- Abnormal liver function
- Patients with renal impairment (eGFR ≤ 60 ml/min)
- Previous history of bladder cancer
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 |
|---|---|---|
| Dapagliflozin 5Mg TabAlso: DigliflozDapagliflozin 5mg tablets daily | Drug | dapagliflozin |
| Glimepiride 4Mg TabAlso: AmarylGlimepiride Tablets daily | Drug | glimepiride |
Primary outcome
Blood Sugar (mg/dl)
Time frame: three months
serum blood glucose
HbA1c %
Time frame: three months
Glycated Hemoglobin
3 secondary outcomes
NT-Pro BNP (ng/ml)
Time frame: Three Months
IRAPe (ng/ml)
Time frame: Three Months
IL-34 (pg./ml)
Time frame: Three 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 Apr 2023.
- Results publication: PubMed 24320621Monami M, Nardini C, Mannucci E. Efficacy and safety of sodium glucose co-transport-2 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2014 May;16(5):457-66. doi: 10.1111/dom.12244. Epub 2013 Dec 29.
- Results publication: PubMed 26354881Abdul-Ghani MA, Norton L, DeFronzo RA. Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus. Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F889-900. doi: 10.1152/ajprenal.00267.2015. Epub 2015 Sep 9.
- Results publication: PubMed 25414933Davidson JA, Kuritzky L. Sodium glucose co-transporter 2 inhibitors and their mechanism for improving glycemia in patients with type 2 diabetes. Postgrad Med. 2014 Oct;126(6):33-48. doi: 10.3810/pgm.2014.10.2819.
- Derived from this study: PubMed 37072577Zekry R, Omran GA, El-Gharbawy NM, Werida RH. Comparative study of Dapagliflozin versus Glimepiride effect on insulin regulated aminopeptidase (IRAP) and interleukin-34 (IL-34) in patient with type 2 diabetes mellitus. Sci Rep. 2023 Apr 18;13(1):6302. doi: 10.1038/s41598-023-33417-3.
- 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.
Nashwa EL-Gharabawy, Lecturer study chair
Tanta University
Rehab Werida study director
Damanhour 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?
An observational study of Diabetes Mellitus, Type 2, 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 2 inclusion and 5 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 Apr 2023. 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?
Blood Sugar (mg/dl) (time frame: three months). 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?
On the ClinicalTrials.gov record for NCT04240171, which also lists 4 linked publications.
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 Apr 2023.