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| Name | Class |
|---|---|
| Beni-Suef University | OTHER |
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Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 50 mg twice daily | Active Comparator | sitagliptin 50 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. |
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| Empagliflozin 12.5 twice daily | Active Comparator | Empagliflozin 12.5 mg is added for 12 weeks to T2DM not controlled with diet, exercise and metformin with or without other oral antidiabetic drugs. |
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| Sitagliptin 50 mg + empagliflozin 12.5 mg | Active Comparator | empagliflozin 12.5 mg is added to the patients with HbA1c 7-10 % of sitagliptin 50 mg group for another 12 weeks. |
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| Empagliflozin 12.5 + sitagliptin 50mg | Active Comparator | sitagliptin 50 mg is added to the patients with HbA1c 7-10 % of empagliflozin 12.5 mg group for another 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin 50 mg | Drug | Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group | The primary efficacy endpoint will be evaluated as clinical cure after 12 weeks of addition of sitagliptin or empagliflozin to metformin and after 12 weeks after adding empaglifozin to sitagliptin group and vise versa. Clinical cure defined by A1C controlled (less than 7%), decrease in fasting and postprandial plasma glucose (mg/dl). | After completion of the study (One year anticipated) |
| Measure | Description | Time Frame |
|---|---|---|
| The decrease in the body weight in patients in sitagliptin group versus empagliflozin group | The decreased in body weight (Kg) from the baseline measures after therapy. | After completion of the study (One year anticipated) |
| The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adverse effects appeared in patients in sitagliptin group versus percentage of adverse effects appear in patients in the empagliflozin group. | AEs (n%) included all events with an onset after the first dose of open label emoagliflozin or sitagliptin and up to 7 days after the last dose of study drug. AEs of special interest included hypoglycaemia, genitourinary infections, hypersensitivity reactions, diabetic ketoacidosis, acute pancreatitis, hypotension, and dehydration. Confirmed hypoglycemic AEs were defined as events with a plasma glucose concentration of ≤ 3.9 mmol/L. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sadat City | El Sadat | 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 |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| C570240 | empagliflozin |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Empagliflozin 12.5 MG | Drug | Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks. |
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| Sitagliptin 50 mg + Empagliflozin 12.5 MG | Drug | Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%) |
|
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| Empagliflozin 12.5 MG + Sitagliptin 50 mg | Drug | Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%) |
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decrease in blood pressure is defined as the decrease in SBP and/or DBP (mmHg) from the baseline measures after completing therapy |
| After completion of the study (One year anticipated) |
| The change in lipid profile in patients in sitagliptin group versus empagliflozin group | Change in lipid profile including decreasing in the following measures from the baseline measures after therapy is completed: low density lipoprotein (mg/dl), total cholesterol (mg/dl), triglyceride (mg/dl) and high density lipoprotein (mg/dl). | After completion of the study (One year anticipated) |
| After completion of the study (One year anticipated) |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |