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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_541 | Other Identifier | Merck |
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The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Active Comparator | Part I of the trial |
|
| Part 2 | Active Comparator | Part II of the trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoglycemic Clamp | Drug | Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) | Baseline and 30 hours | |
| Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine | Baseline and 30 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine | Baseline and 30 hours | |
| Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) |
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Inclusion Criteria:
Part 1:
Part 2:
Exclusion Criteria:
Part 1:
Part 2:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Comparator: insulin glargine | Drug | Insulin glargine at 0.4 U/kg |
|
|
| Baseline and 30 hours |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |