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Comparing the effectiveness of Empagliflozin with Metformin in controlling Diabetes Mellitus in patients with post-organ transplant diabetes

Phase 3
Recruiting
Conditions
Post Transplant Diabetes Mellitus.
Other specified diabetes mellitus
Registration Number
IRCT20230315057726N1
Lead Sponsor
Islamic Azad University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

At least 6 months have passed since the patient's transplant
No previous history of diabetes and use of any blood sugar-lowering medication
Diagnosing diabetes according to the criteria of the American Diabetes Association
HbA1c< 8%
HbA1c>6.5%

Exclusion Criteria

Rejection of the transplanted organ in the patient
Transplanted organ failure
Pregnancy
Age less than 18 years
Any contraindication related to empagliflozin (allergy to the drug or its components, dialysis, diabetic ketoacidosis, hospitalization)
The patient's unwillingness to participate in the study
BMI above 40
Severe liver failure (enzymes more than 3 times the normal limit)
or renal failure (creatinine more than 2), creatinine clearance below 60
Any contraindication related to Metformin (allergy to the drug or its components, dialysis, diabetic ketoacidosis, hospitalization)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
HbA1c. Timepoint: To compare the effectiveness of two drugs, empagliflozin and metformin, HbA1C of patients with Post Transplant Diabetes Mellitus(PTDM) is measured at the beginning of the study and 90 days after taking the drug. Method of measurement: Blood Sample.
Secondary Outcome Measures
NameTimeMethod
FBS (fasting blood sugar). Timepoint: To compare the effectiveness of two drugs, empagliflozin and metformin, FBS of patients with Post Transplant Diabetes Mellitus(PTDM) is measured at the beginning of the study and 90 days after taking the drug. Method of measurement: Blood Sample.
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