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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
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Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices
A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premixed Insulin | Active Comparator | Premixed Human Insulin |
|
| Premixed insulin | Active Comparator | Premixed Insulin Analog |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premixed Human Isophane Insulin Suspension + Human Insulin Injection | Drug | premixed human insulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in average blood glucose | average blood glucose (mg/dl) from continuous glucose monitoring | 7 days |
| Glycated Albumin | levels of glycated albumin (%) in serum | 7 days |
| Fructosamine | levels of fructosamine (μmol/L) in serum | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Insulin requirements | change in total daily dose of insulin (u) | 7 days |
| nocturnal average blood glucose | change in nocturnal average blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Triantafyllos Didangelos, Assoc. Prof. | AHEPA Hospital Aristotle University Of Thessaloniki | Principal Investigator |
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Upon request
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Cross-over
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| Premixed Insulin | Drug | Premixed Insulin Analog Biphasic Aspart 30 |
|
|
| 7 days |
| Time in range | change in time in range (% and minutes) from continuous glucose monitoring | 7 days |
| time above 180 | change in time above 180 (% and minutes) from continuous glucose monitoring | 7 days |
| time below 70 | change in time below 70 (% and minutes) from continuous glucose monitoring | 7 days |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |