Status:
COMPLETED
Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes
Lead Sponsor:
Beni-Suef University
Collaborating Sponsors:
Minia University
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.
Detailed Description
This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.
Eligibility Criteria
Inclusion
- Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.
Exclusion
- Type1 diabetes or ketoacidosis
- End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
- Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
- Any stage of heart failure
- Previous history of pancreatitis
- Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)
- Pregnant or lactating females
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04916093
Start Date
December 20 2019
End Date
December 15 2020
Last Update
June 7 2021
Active Locations (1)
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1
Minya University Hospital
Minya, Egypt, 61118