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The purpose of this study is to evaluate the Effect on Post-prandial Glycemia Safety, and Tolerability of Viaject 7 vs. Lispro Insulin during SC Insulin Pump Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation A | Experimental | Single Injection |
|
| Formulation B | Experimental | Single Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viaject 7 | Drug | 100IU/mL administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 3 hour incremental area under the glucose curve after a standardized high glycemic index meal. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Draize scores at insulin infusion site at 24 hour and 72 hour follow-up visits, frequency of discomfort with insulin infusion, and severity of discomfort with insulin infusion (ratings of mild, moderate, or severe). | 72 hours |
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Inclusion Criteria:
Males or females diagnosed with type 1 diabetes mellitus for at least 6 months
Current usage of subcutaneous insulin pump treatment with one of the following pumps:
Age 18-75 years
HbA1c of 6.0 - 9.0% at screening visit.
Willingness to attend 9 clinic visits.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University/Legacy Health System | Portland | Oregon | 97232 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| LISPRO |
| Drug |
100IU/mL administered subcutaneously |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |