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| ID | Type | Description | Link |
|---|---|---|---|
| 078 | |||
| 2009_695 |
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A two period pilot study to determine if a graded glucose infusion using a glucose (20% dextrose [D20]) intravenous infusion can be properly implemented and will be well tolerated in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 + Period 2 | Experimental | graded infusion of intravenous glucose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: graded infusion of intravenous glucose | Procedure | A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12mg/kg/min. Procedure will be identical in Period 1 and Period 2. |
| Measure | Description | Time Frame |
|---|---|---|
| proper implementation and tolerability of a grade glucose infusion using D20 intravenous infusion measured by glucose, insulin and C-peptide levels | 0-160 minutes after start of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) | 0-160 minutes after start of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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