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

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

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2020-12-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Sitagliptin Group

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

Group Type EXPERIMENTAL

Sitagliptin 100mg

Intervention Type DRUG

Januvia 100mg oral tablets

Vildagliptin Group

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

Group Type EXPERIMENTAL

Vildagliptin 50 MG

Intervention Type DRUG

Galvus 50 mg oral tablets

Metformin Group

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

Group Type ACTIVE_COMPARATOR

MetFORMIN 1000 Mg Oral Tablet

Intervention Type DRUG

Glucophage 1000 mg oral tablets

Interventions

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Vildagliptin 50 MG

Galvus 50 mg oral tablets

Intervention Type DRUG

Sitagliptin 100mg

Januvia 100mg oral tablets

Intervention Type DRUG

MetFORMIN 1000 Mg Oral Tablet

Glucophage 1000 mg oral tablets

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No