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

Study Overview
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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.

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.

Official Title
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Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Vildagliptin 50 MG
* Drug: Sitagliptin 100mg
* Drug: MetFORMIN 1000 Mg Oral Tablet


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin Group<br>Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast. | Drug: Sitagliptin 100mg<br>* Januvia 100mg oral tablets<br>|
| Experimental: Vildagliptin Group<br>Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper. | Drug: Vildagliptin 50 MG<br>* Galvus 50 mg oral tablets<br>|
| Active Comparator: Metformin Group<br>Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily | Drug: MetFORMIN 1000 Mg Oral Tablet<br>* Glucophage 1000 mg oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glycemic parameters | serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl) | 3-months | 
| Changes in Serum insulin (IU/l) | using enzyme immunoassay (EIA) kits | 3-months | 
| Insulin resistance | measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405 | 3-months | 
| Beta cell function (HOMA-B) | measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63) | 3-months | 
| Changes in HbA1c (%) | Changes in HbA1c (%) | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Lipid profile | (total cholesterol, TG, HDL, and LDL) (mg/dl) | 3-months | 
| Changes in liver enzymes | ALT and AST (U/l) | 3-months | 
| Changes in Renal function tests | creatinine and urea (mg/dl) | 3-months |