Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes

Beni-Suef University

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: MetFORMIN 1000 Mg Oral Tablet; Drug: Sitagliptin 100mg; Drug: Vildagliptin 50 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04916093

MinyaU

Details and patient eligibility

About

The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.

Exclusion criteria

1. Type1 diabetes or ketoacidosis
2. End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
3. Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
4. Any stage of heart failure
5. Previous history of pancreatitis
6. Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)
7. Pregnant or lactating females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Sitagliptin Group

Experimental group

Description:

Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast.

Treatment:

Drug: Sitagliptin 100mg

Vildagliptin Group

Experimental group

Description:

Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper.

Treatment:

Drug: Vildagliptin 50 MG

Metformin Group

Active Comparator group

Description:

Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily

Treatment:

Drug: MetFORMIN 1000 Mg Oral Tablet