CLINICAL TRIALS PROFILE FOR EXENATIDE SYNTHETIC
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All Clinical Trials for exenatide synthetic
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00082407 ↗ | Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin | Completed | Eli Lilly and Company | Phase 3 | 2003-11-01 | This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c). |
| NCT00082407 ↗ | Exenatide Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin | Completed | AstraZeneca | Phase 3 | 2003-11-01 | This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c). |
| NCT01046721 ↗ | Study Looking at Cardiovascular Effects of Exenatide, Its Blood Pressure Lowering Effect and Its Mechanisms | Completed | University of Nottingham | N/A | 2009-09-01 | Exenatide is a new drug which lowers blood sugar (glucose) levels for people with type 2 diabetes. It has significant advantages over other treatments such as insulin as it causes weight loss in a group of people that is generally overweight. Data from studies involving exenatide have shown that it also has an effect on blood pressure. The mechanism for the blood pressure lowering effect is not known and has not been investigated previously. Exenatide may have an effect on blood vessels throughout the body and gut to reduce blood pressure. 12 healthy men (18-45yr) will be studied on 2 occasions. Limb blood flow, skin blood flow, gut blood flow, blood pressure, and heart rate will be measured half hourly for 4 hours. Blood samples (3ml) for insulin and glucose determination will be taken via a cannula and 3-way tap at the same time points. A dose of either 5μg exenatide or saline will be injected under the skin of the abdomen and a breakfast will be provided during the study. A urine collection will be made over the duration of the study. |
| NCT01056549 ↗ | Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans | Completed | Eli Lilly and Company | N/A | 2010-01-01 | Exenatide acutely inhibits intestinal lipoprotein particle production. We are unable to speculate whether exenatide affects hepatic lipoprotein production in humans since there is currently no evidence from animal models or in vitro studies that have demonstrated an effect |
| NCT01056549 ↗ | Exenatide (Byetta ®) Regulation of Intestinal and Hepatic Lipoprotein Particle Production in Humans | Completed | University Health Network, Toronto | N/A | 2010-01-01 | Exenatide acutely inhibits intestinal lipoprotein particle production. We are unable to speculate whether exenatide affects hepatic lipoprotein production in humans since there is currently no evidence from animal models or in vitro studies that have demonstrated an effect |
| NCT01444898 ↗ | Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome | Completed | Children's Hospital Los Angeles | N/A | 2012-03-01 | Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity. Obesity is a major source of morbidity and mortality in this population. It can lead to sleep apnea, cor pulmonale, diabetes mellitus, and atherosclerosis. PWS has distinct characteristics that set it apart from other forms of obesity including insatiable appetite and food-seeking behavior which can be disruptive to home and school activities, and can cause severe social and psychological turmoil within families. PWS is also associated with unique hormonal abnormalities, most notably hyperghrelinemia. Ghrelin is a gut hormone produced in the stomach that stimulates food intake during a fast. It is hypothesized that the extremely high ghrelin levels in patients with PWS may cause or contribute to their insatiable appetite. Exenatide, a medication used in the treatment of type 2 diabetes mellitus in adults, appears to suppress ghrelin levels and cause weight loss. It was designed to mimic glucagon-like peptide 1 (GLP-1), an incretin hormone that stimulates insulin secretion and delays gastric emptying, among other effects. In the present study, the investigators will investigate the effects of a 6 month trial of exenatide in overweight adolescents with PWS. The investigators will quantify the changes in weight and body composition, as well as subjective measures of appetite, and concentrations of appetite-associated hormones. The investigators hypothesize that exenatide will improve weight, body composition, appetite, and plasma ghrelin levels during the treatment period. |
| NCT01776788 ↗ | Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients | Completed | The First Affiliated Hospital of Xiamen University | Phase 4 | 2012-08-01 | The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients. |
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