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Decision by Sponsor
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The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 876 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 876 | Drug | Ascending single doses of study drug administered SC, with one cohort administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of treatment-emergent adverse events | Physical examinations, vitals, clinical laboratories, and ECGs | 29 days |
| Safety laboratory analytes, vital signs, and ECGs | laboratory analytes, vital signs, and ECGs | 29 days |
| Subject incidence of anti-AMG 876 antibodies. | laboratories analytes | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| AMG 876 serum PK parameters | Concentration-time profiles for AMG 876 | 29 days |
| Pharmacodynamic parameters: | Concentration of fasting glucose, insulin and c-peptide levels; Concentration-time profiles and AUC for metabolic parameters (eg, glucose, insulin, c-peptide, glucagon and free fatty acid concentrations) following a mixed meal tolerance test; Lipid levels (ie, total cholesterol, LDL, HDL, and triglycerides); Body weight. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Omaha | Nebraska | 68154 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 29 days |
| San Antonio |
| Texas |
| 78209 |
| United States |
| San Antonio | Texas | 78209 | United States |