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This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosiglitazone | Drug | |||
| metformin | Drug | |||
| PN2034 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Effect on HbA1c levels |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on glucose control as measured by FPG | ||
| 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 | ||
| University Clinical Research-DeLand |
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| DeLand |
| Florida |
| 32720 |
| United States |
| Center for Diabetes and Endocrine Care | 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 |
| Palmetto Medical Research Associates | Mt. Pleasant | South Carolina | 29464 | 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 |
|---|---|
| D000077154 | Rosiglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
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