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This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent type 2 diabetics as measured by the change in average daily insulin dose from baseline to week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will also be measured.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN2034 | Drug | |||
| Insulin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Effect on change in average daily insulin dose |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on HbA1c levels | ||
| Effect on FPG levels | ||
| Effect on lipid levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Internal Medicine Associates | Waterbury | Connecticut | 06708 | United States | ||
| Center for Diabetes and Endocrine Care |
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| Hollywood |
| Florida |
| 33021 |
| United States |
| Genesis Research International | Longwood | Florida | 32779 | United States |
| Baptist Diabetes Associates | Miami | Florida | 33156 | United States |
| Andres Patron, DO PA | Pembroke Pines | Florida | 33028 | United States |
| CLIRECO,Inc. | Tamarac | Florida | 33321 | United States |
| Endocrine Clinical Research | Winter Park | Florida | 32789 | United States |
| PRN of Kansas | Wichita | Kansas | 67203 | United States |
| Medical Research Associates of Charlotte | Charlotte | North Carolina | 28211 | United States |
| Neem Research Group of Charlotte | Charlotte | North Carolina | 28262 | United States |
| Unifour Medical Research Associates | Hickory | North Carolina | 28601 | United States |
| Neem Research Group of Raleigh | Raleigh | North Carolina | 27609 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| COR Clinical Research, LLC | Oklahoma City | Oklahoma | 73103 | United States |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | 97504 | United States |
| Camp Hill Clinical Research Center | Camp Hill | Pennsylvania | 17011 | United States |
| Neem Research Group | Columbia | South Carolina | 29201 | United States |
| Oaks Medical Center | Spring | Texas | 77386 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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