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| ID | Type | Description | Link |
|---|---|---|---|
| Alfred Study No. 409/12 | Other Identifier | Baker IDI Heart and Diabetes Institute |
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| Name | Class |
|---|---|
| Baker Heart and Diabetes Institute | OTHER |
| Nucleus Network Ltd | OTHER |
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This study builds on data that high-density lipoprotein (HDL) has a number of potentially beneficial effects including directly modulating glucose metabolism through multiple mechanisms. The primary objective of this study is to determine the effects of RVX000222 on postprandial plasma glucose in male individuals with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), during a frequently sampled oral glucose tolerance test (OGTT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RVX000222, 200 mg daily | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RVX000222 | Drug | capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma glucose following treatment with RVX000222 compared to placebo | The change in postprandial plasma glucose, defined as area under the glucose curve (AUGC) during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo. | 29-33 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin secretion and insulin sensitivity following treatment with RVX000222 compared to placebo | The change in indices of insulin secretion (β-cell function) and insulin sensitivity during a frequently sampled OGTT following RVX000222 treatment for 29-33 days as compared to placebo. | 29-33 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Bronwyn Kingwell | Baker Heart and Diabetes Institute | Principal Investigator |
| Dr. Stephen Duffy | Baker Heart and Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baker IDI Heart and Diabetes Institute 75 Commercial Road, | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000628794 | apabetalone |
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| Placebo, RVX000222 | Drug | capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days |
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