Diabetes Mellitus, Type 2NCT03907423
Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin
A study testing Rosuvastatin10 mg tablet in people with Diabetes Mellitus, Type 2, run by Rehab Werida at 1 site in Egypt.
Trial summary
study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients treated with glimepiride/metformin without coronary artery disease. This effect will be investigated especially on sortilin ,fetuin-A Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Rosuvastatin10 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 31 Jan 2021
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus on oral therapy.
- Age 21-65 years
- Life expectancy >1 year.
Who cannot join
- Documented CVD
- Planned surgical intervention.
- Hypersensitivity to either of the study drug components.
- Type I diabetes.
- Current Insulin treatment.
- Hepatic impairment known hepatic failure.
Show all 11Show fewer
- Inability to comply with study protocol.
- Active malignancy.
- Chronic inflammation (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
- Pregnancy, lactation or child-bearing potential.
- Chronic renal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Damanhour Medical National Institute
Damanhūr, N/A = Not Appُlicable, 31527
About this study
Official title: Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination
study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients treated with glimepiride/metformin without coronary artery disease.
This effect will be investigated especially on sortilin ,fetuin-A
Read the detailed description
A randomized controlled trial on 70 patients with DM type 2 will be recruited from Damanhour national medical institute.
- Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
- Determination of serum levels of fetuin A and Sortilin
- Blood samples will be collected after 3-month after active treatment.
- Outcomes measurement : Sortilin ,fetuinA, Atherogenic index (AI) and coronary risk index (CRI) .
Methodology
- Sortilin, fetuinA will be determined by ELISA.
- Lipid profile.
- FBG and Hb A1C will be measured.
- Atherogenic index (AI = LDL-C/HDL-C) and CRI (CRI = TC/HDL-C) will be calculated for all subjects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Rosuvastatin10 mg tablet, Placebo Oral Tablet
- Keywords
- T2DM.
- 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.
Rosuvastatin10 mg tabletDrug
Also called Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Placebo Oral TabletDrug
Also called Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) Receives: Drug: Rosuvastatin10 mg tablet |
| Placebo Group | Placebo comparator | DM-type 2 patient who will receive glimepiride-metformin combination (30 patients). Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of fetuin A
Fetuin-A has a diagnostic potential as a biomarker for liver dysfunction, cardiovascular diseases and disorders associated with metabolic syndrome.
Measured: three months
serum levels of Sortilin
Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment.
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 posted9 Apr 2019
- Study start1 Apr 2019
- Primary completion19 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass.Prof., Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907423
- Sponsor's protocol ID
- Rosuvastatin on diabetics
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oh TJ, Ahn CH, Kim BR, Kim KM, Moon JH, Lim S, Park KS, Lim C, Jang H, Choi SH. Circulating sortilin level as a potential biomarker for coronary atherosclerosis and diabetes mellitus. Cardiovasc Diabetol. 2017 Jul 20;16(1):92. doi: 10.1186/s12933-017-0568-9.
PubMed 28728579Dabrowska AM, Tarach JS, Wojtysiak-Duma B, Duma D. Fetuin-A (AHSG) and its usefulness in clinical practice. Review of the literature. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Sep;159(3):352-9. doi: 10.5507/bp.2015.018. Epub 2015 Apr 24.
PubMed 25916279
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination
- ClinicalTrials.gov ID
- NCT03907423
- Acronym / sponsor ID
- Rosuvastatin on diabetics
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- T2DM.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 9 Apr 2019 (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.
study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients treated with glimepiride/metformin without coronary artery disease.
This effect will be investigated especially on sortilin ,fetuin-A
Detailed description
A randomized controlled trial on 70 patients with DM type 2 will be recruited from Damanhour national medical institute.
- Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
- Determination of serum levels of fetuin A and Sortilin
- Blood samples will be collected after 3-month after active treatment.
- Outcomes measurement : Sortilin ,fetuinA, Atherogenic index (AI) and coronary risk index (CRI) .
Methodology
- Sortilin, fetuinA will be determined by ELISA.
- Lipid profile.
- FBG and Hb A1C will be measured.
- Atherogenic index (AI = LDL-C/HDL-C) and CRI (CRI = TC/HDL-C) will be calculated for all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin10 mg tabletDM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) |
| Placebo Group | Placebo comparator | Drug: Placebo Oral TabletDM-type 2 patient who will receive glimepiride-metformin combination (30 patients). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus on oral therapy.
- Age 21-65 years
- Life expectancy >1 year.
Key exclusion criteria (11 listed)
- Documented CVD
- Planned surgical intervention.
- Hypersensitivity to either of the study drug components.
- Type I diabetes.
- Current Insulin treatment.
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 |
|---|---|---|
| Rosuvastatin10 mg tabletAlso: Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oralDiabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral | Drug | Rosuvastatin |
| Placebo Oral TabletAlso: Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oralDiabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral | Drug | Placebo Group |
Primary outcome
serum levels of fetuin A
Time frame: three months
Fetuin-A has a diagnostic potential as a biomarker for liver dysfunction, cardiovascular diseases and disorders associated with metabolic syndrome.
serum levels of Sortilin
Time frame: three months
Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment.
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 14 Apr 2023.
- Background: PubMed 28728579Oh TJ, Ahn CH, Kim BR, Kim KM, Moon JH, Lim S, Park KS, Lim C, Jang H, Choi SH. Circulating sortilin level as a potential biomarker for coronary atherosclerosis and diabetes mellitus. Cardiovasc Diabetol. 2017 Jul 20;16(1):92. doi: 10.1186/s12933-017-0568-9.
- Background: PubMed 25916279Dabrowska AM, Tarach JS, Wojtysiak-Duma B, Duma D. Fetuin-A (AHSG) and its usefulness in clinical practice. Review of the literature. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Sep;159(3):352-9. doi: 10.5507/bp.2015.018. Epub 2015 Apr 24.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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. principal investigator
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 Rosuvastatin10 mg tablet in people with Diabetes Mellitus, Type 2, run by Rehab Werida 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 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 14 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. Some participants in this study may receive a placebo. 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?
serum levels of fetuin A (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 NCT03907423, which also lists 2 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 14 Apr 2023.