NCT03907423

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

April 5, 2019

Last Update Submit

April 12, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

T2DM.

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    three months

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients)

Drug: Rosuvastatin10 mg tablet

Placebo Group

PLACEBO COMPARATOR

DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).

Drug: Placebo Oral Tablet

Interventions

Rosuvastatin10 mg tabletDRUG

Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Also known as: Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Rosuvastatin
Placebo Oral TabletDRUG

Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Also known as: Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Placebo Group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus on oral therapy.
  • Age 21-65 years
  • Life expectancy \>1 year.

You may not qualify if:

  • Documented CVD
  • Planned surgical intervention.
  • Hypersensitivity to either of the study drug components.
  • Type I diabetes.
  • Current Insulin treatment.
  • Hepatic impairment known hepatic failure.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Medical National Institute

Damanhūr, N/A = Not Appُlicable, 31527, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 28728579BACKGROUND

  • Dabrowska 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.

    PMID: 25916279BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepirideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Rehab H Werida, Ass.Prof.

    Damanhour University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 9, 2019

Study Start

April 1, 2019

Primary Completion

January 19, 2021

Study Completion

January 31, 2021

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)