Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?
NCT ID: NCT05359341
Last Updated: 2022-05-03
Study Results
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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COMPLETED
NA
175 participants
INTERVENTIONAL
2020-09-20
2022-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sitagliptin 50 mg twice daily
sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs.
Sitagliptin 50 mg
Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
Empagliflozin 12.5 twice daily
Empagliflozin 12.5 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs.
Empagliflozin 12.5 MG
Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
Sitagliptin 50 mg + empagliflozin 12.5 mg
empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks.
Sitagliptin 50 mg + Empagliflozin 12.5 MG
Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)
Empagliflozin 12.5 + sitagliptin 50mg
sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks.
Empagliflozin 12.5 MG + Sitagliptin 50 mg
Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)
Interventions
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Sitagliptin 50 mg
Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
Empagliflozin 12.5 MG
Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
Sitagliptin 50 mg + Empagliflozin 12.5 MG
Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)
Empagliflozin 12.5 MG + Sitagliptin 50 mg
Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 20-70 years
* A1C less than 10.5%
Exclusion Criteria
* Pregnancy
* Chronic liver disease
* Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
* High bilirubin
* Albumin \< 3.5 g/dl
* INR \>1-2 Diabetic ketoacidosis
* Urinary tract infection (UTI)
* Pancreatitis \< 6 months prior to enrolment
* Renal impairment (creatinine clearance ≤50 ml/min)
* Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment
* Non-compliance with follow-up visits.
20 Years
70 Years
ALL
No
Sponsors
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Beni-Suef University
OTHER
Sadat City University
OTHER
Responsible Party
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Haitham Galal
Teaching assistant (MSC) in Clinical Pharmacy Department
Locations
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University of Sadat City
El Sadat, , Egypt
Countries
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Other Identifiers
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09/2020
Identifier Type: -
Identifier Source: org_study_id
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