Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-01-31

Brief Summary

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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

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Detailed Description

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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

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rosuvastatin

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

Group Type EXPERIMENTAL

Rosuvastatin10 mg tablet

Intervention Type DRUG

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

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

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

Interventions

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Rosuvastatin10 mg tablet

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

Intervention Type DRUG

Placebo Oral Tablet

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No