Clinical trial

Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination

Name

Rosuvastatin on diabetics

Description

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 arms

Trial start

2019-04-01

Estimated PCD

2021-01-19

Trial end

2021-01-31

Status

Completed

Treatment

Rosuvastatin10 mg tablet

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

Arms:

Rosuvastatin

Other names:

Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Placebo Oral Tablet

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

Arms:

Placebo Group

Other names:

Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

Size

Primary endpoint

serum levels of fetuin A

three months

serum levels of Sortilin

three months

Eligibility criteria

Inclusion Criteria: * Type 2 diabetes mellitus on oral therapy. * Age 21-65 years * Life expectancy \>1 year. Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

Updated at

2023-04-14

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug