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| Name | Class |
|---|---|
| Meshal Saud Alotaibi, Senior Clinical Pharmacist, King Salman Speicialist Hospital-Hail, K.S.A. | UNKNOWN |
| Tanta University | OTHER |
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Type 1 Diabetes (T1DM) is a disease characterised by immune mediated destruction of the insulin-producing pancreatic beta cells. Overtime, obvious insulin deficiency develops which requires insulin therapy. T1DM accounts for about 5% to 10% of diabetes cases in Europe and United States. Currently, worldwide incidence is estimated to be around 15 per 100,000 people per year. Despite the advancement that has occurred in the field diabetes therapy, patient with T1DM still suffer from managing their disease as well as continuing to face diabetes related complications. The American Diabetes Association (ADA) recommend a goal of glycated haemoglobin (HbA1c) of < 7%. However, only 21% of adults in the United States has achieved this recommended goal. Once again, a multinational, multicentre study shows that only 24.3% of participants achieved the glycaemic target of HbA1c less than 7.0 %. Unfortunately, intensifying the insulin therapy in order to reach the targeted HbA1c can result in serious adverse effects of hypoglycaemia and weight gain which is in its turn is known risk factor for cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | standard treatment group (control) that will be 35 patients who will receive multiply daily injections of insulin (basal/bolus) for 3 months. |
|
| Semaglutide group | Active Comparator | will include 35 patients who in addition to insulin (basal/bolus) will receive semaglutide 0.25 mg Sc once weekly for 1 month then increase to 0.5 mg SC once weekly for 2 months. |
|
| Empaglflozin group | Active Comparator | will include 35 patients who will receive empagliflozin 10 mg orally once daily in addition to insulin (basal/bolus) for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Insulin is a naturally occurring hormone your pancreas makes that's essential for allowing your body to use sugar (glucose) for energy. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment. | The primary outcome of this trial is the change in glycated haemoglobin from baseline after 3 months of treatment. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) syndrome; family history of multiple endocrine neoplasia, type 2A (MEN 2A), medullary thyroid cancer, or familial medullary thyroid cancer.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta Unuversity | Recruiting | Tanta | 31527 | Egypt |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| C000591245 | semaglutide |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Semaglutide | Drug | Semaglutide is long acting glucagon like peptide which is parenterally administered as subcutaneous injection once weekly with a half-life of about 7 days |
|
| Empagliflozin | Drug | Empagliflozin lowers blood glucose levels by preventing glucose reabsorption in the kidneys, thereby increasing the amount of glucose excreted in the urine |
|
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |