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To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. 3 consecutive days after switching back to bedtime dosing of insulin glargine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLARGINE | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime |
| Measure | Description | Time Frame |
|---|---|---|
| Compare % subjects with glucose measurements < or = to 72 mg/dL & < or = to 36 mg/dL at any point of the 8-point glucose profile during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime | |
| To compare the mean daily rate of hypoglycemia during 3 consecutive days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Diaz | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Monterrey | Mexico |
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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 |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime |
| To compare the changes from baseline in glucose values at each specific measurement time of the 8-point glucose profile during 3 consecutive days | before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime |
| To compare the incidence of symptomatic hypoglycemia | at any time during 3 consecutive days before vs. after switching dosing time from bedtime to morning and vs. after switching back to bedtime |
| To evaluate overall safety and tolerability based on adverse event reporting, laboratory tests, and clinical examinations | at any time during the study |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |