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PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| PF-04603629 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Subjects will be given either Placebo or PF-04603629. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM. | 1 week per dose group | |
| To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM. | 1 week per dose group | |
| To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM. | 1 week per dose group |
| Measure | Description | Time Frame |
|---|---|---|
| No secondary outcomes listed in the protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Phoenix | Arizona | 85013 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C569029 | PF 04603629 |
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| PF-04603629 |
| Biological |
Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg. |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| D004700 | Endocrine System Diseases |