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Insulin is a chemical that the body needs in order to use or store sugar. It is made by a type of cell called a beta cell which resides in an organ known as the pancreas. Type 1 diabetes is a disease where the beta cells have been destroyed so that little or no insulin is made. Sugar levels rise in the blood as a result. INGAP-Peptide is being tested to attempt to create new beta cells in the pancreas, and to restore the ability to produce insulin in type 1 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | 1.5 mL SC injection |
|
| 300 mg INGAP Peptide | Experimental | 1.5 mL SC injection, once daily for 90 days |
|
| 600 mg INGAP Peptide | Experimental | 1.5 mL SC injection, once daily for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INGAP-Peptide | Drug | 1.5 mL, once daily, self-administered SC injection for 90 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| assess efficacy and safety based on arginine stimulated C peptide, fasting C peptide, average daily insulin dose, fasting glucose, glycosylated hemoglobin (Hb A1c), and AEs | 90 days |
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Inclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Irvine | California | 92618 | United States | ||
| VA Hospital UCSD |
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| INGAP-Peptide |
| Drug |
1.5 mL, once daily, self-administered SC injection for 90 days |
|
| placebo | Drug | 1.5 mL, once daily, self-administered SC injection for 90 days |
|
| San Diego |
| California |
| 92161 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| MedStar Clinical Research Center | Washington D.C. | District of Columbia | 20003 | United States |
| Springfield Diabetes and Endocrine Center | Springfield | Illinois | 62704 | United States |
| Mercury Street Medical | Butte | Montana | 59701 | United States |
| UNC Diabetes Care Center | Durham | North Carolina | 27713 | United States |
| Clinical Research Institute of Southern Oregon | Medford | Oregon | 97504 | United States |
| University of Texas Health Science Center - Texas Diabetes Institute | San Antonio | Texas | 78207 | United States |
| DGD Research Associates | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C500438 | INGAP peptide |
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