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| Name | Class |
|---|---|
| Minia University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin Group | Experimental | Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast. |
|
| Vildagliptin Group | Experimental | Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper. |
|
| Metformin Group | Active Comparator | Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin 50 MG | Drug | Galvus 50 mg oral tablets |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asmaa A Elsayed, Master | BUC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minya University Hospital | Minya | 61118 | Egypt |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Sitagliptin 100mg |
| Drug |
Januvia 100mg oral tablets |
|
| MetFORMIN 1000 Mg Oral Tablet | Drug | Glucophage 1000 mg oral tablets |
|
| Changes in Renal function tests | creatinine and urea (mg/dl) | 3-months |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |