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| Name | Class |
|---|---|
| IKFE Institute for Clinical Research and Development | OTHER |
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The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Glulisine: bolus injections before each main meal | Experimental | Patients are already on an Insulin Glargine therapy when they start and will them after randomization receive additionally Insulin Glulisine bolus injections before each of the main meals. |
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| Insulin Aspart: bolus injections before each main meal | Active Comparator | Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally Insulin Aspart bolus injections before each of the main meals. |
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| Regular human insulin:bolus injections before each main meal | Active Comparator | Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally regular human insulin bolus injections before each of the main meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glulisine | Drug | Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. |
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| Measure | Description | Time Frame |
|---|---|---|
| Nitrotyrosine | The difference in the percent increase of the oxidative stress biomarker nitrotyrosine after stimulation with a standardized meal | Baseline, after 10 weeks, after 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skin blood flow | Change in skin blood flow during stimulation by a standardized meal | Baseline, after 10 weeks, after 24 weeks |
| mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ife GmbH, Clinic | Mainz | Rhineland-Palatinate | 55116 | Germany |
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| Insulin aspart | Drug | Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. |
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| Regular human insulin | Drug | Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL. |
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Biomarkers of sub-clinical inflammation and cardiovascular risk: Change in Macrophage activation, MAPK/eNOS production levels, adiponectin and hsCRP (after test meal) from baseline to endpoint
| Baseline, after 10 weeks, after 24 weeks |
| Insulin | Change in Insulin and the ratio from baseline to endpoint | Baseline, after 10 weeks, after 24 weeks |
| HbA1c | Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint | Baseline, after 10 weeks, after 24 weeks |
| Fasting blood glucose | Blood glucose control: Change during test meal, HbA1c and FBG from baseline to endpoint | Baseline, after 10 weeks, after 24 weeks |
| Hypoglycemic events | Incidence of hypoglycemia from baseline to endpoint | Baseline, after 10 weeks, after 24 weeks |
| intact Proinsulin | Change in intact Proinsulin and the ratio from baseline to endpoint | Baseline, after 10 weeks, after 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D061267 | Insulin Aspart |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011384 | Proinsulin |
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