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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK075931 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.
A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.
In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.
There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.
Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.
Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide | Active Comparator | exenatide one dose |
|
| pramlintide | Active Comparator | pramlintide one dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Byetta (exenatide) | Drug | exenatide 5 mcg subcutaneously |
| |
| Symlin (pramlintide) |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | concentration and AUC calculations | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| glucagon | concentration and AUC calculations | 4 hrours |
| gastric emptying | concentration and AUC calculations | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LUISA M RODRIGUEZ, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2020 | |
| Reset | Dec 30, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2020 | Dec 30, 2020 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
|---|---|
| D000077270 | Exenatide |
| C105254 | pramlintide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Drug |
pramlintide 60 mcg subcutaneously |
|
| pramlintide concentrations | concentration and AUC calculations | 4 hours |
| exenatide concentrations | concentration and AUC calculations | 4 hours |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |