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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008486-35 | EudraCT Number |
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The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.
Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biphasic Insulin Aspart 30 | Active Comparator | 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch |
|
| Biphasic Insulin Aspart 70 | Active Comparator | 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch |
|
| Insulin Aspart | Active Comparator | 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart | Drug | Patients received insulin aspart before breakfast and before lunch. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Over Basal for Postprandial Glucose From 0 to 600min | Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
| Area Over Basal for Postprandial Triglycerides | Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Glucose Increase | Maximum glucose increase from baseline to 600min after baseline | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
| Maximum Triglyceride Increase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Sourij, MD | Medical University of Graz, 8036 Graz, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz, Department for Internal Medicine | Graz | 8036 | Austria |
All subjects received all of the three insulins within various sequences in a randomized order. Randomisation lists for the insulin sequence were provided by a researcher otherwise not involved in the clinical trial performance.
50 patients were screened and in total 20 randomizations were performed. After randomization 20 randomized subjects finished all three study visits.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period. |
| FG001 | Group 2 | Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period |
| FG002 | Group 3 | Participants were randomized to each intervention and re-randomized to the remaining interventions after each washout period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Wash Out Period 1 (3 Days) |
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| Second Intervention |
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| Wash Out Period 2 (3 Days) |
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| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | 20 patients with type 2 diabetes receive insulin aspart, premixed biphasic insulin 30 and premixed biphasic insulin aspart 70 in randomized order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Over Basal for Postprandial Glucose From 0 to 600min | Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | Posted | Mean | Standard Deviation | mg*/min/dL | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biphasic Insulin Aspart 30 | Insulin Aspart 30: Patients received biphasic insulin aspart 30 before breakfast and before lunch. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Hypoglycaemic Event | Endocrine disorders | Mild Hypo | Systematic Assessment | Hypoglycaemic events blood glucose levels <70mg/dL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Norbert Tripolt | Medical University of Graz | 0316385 | 78038 | norbert.tripolt@medunigraz.at |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Aspart 30 | Drug | Patients received biphasic insulin aspart 30 before breakfast and before lunch. |
|
|
| Insulin Aspart 70 | Drug | Patients received biphasic insulin aspart 70 before breakfast and before lunch. |
|
|
Maximum trigylceride increase from Baseline to 600min after Baseline
| 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
| Area Over Basal for Postprandial Insulin | Area over basal for postprandial insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
| Area Over Basal for Postprandial C-peptide | Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Measure Type: Count of Participants Unit of measure: participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Insulin Aspart | Insulin Aspart: Patients received insulin aspart before breakfast and before lunch. |
|
|
| Primary | Area Over Basal for Postprandial Triglycerides | Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | Posted | Mean | Standard Deviation | mg*min/dL | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
|
|
|
| Secondary | Maximum Glucose Increase | Maximum glucose increase from baseline to 600min after baseline | Posted | Mean | Standard Deviation | mg/dL | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
|
|
|
| Secondary | Maximum Triglyceride Increase | Maximum trigylceride increase from Baseline to 600min after Baseline | Posted | Mean | Standard Deviation | mg/dL | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
|
|
|
| Secondary | Area Over Basal for Postprandial Insulin | Area over basal for postprandial insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | Posted | Mean | Standard Deviation | µU*min/L | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
|
|
|
| Secondary | Area Over Basal for Postprandial C-peptide | Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule. | Posted | Mean | Standard Deviation | mg*min/mL | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Biphasic Insulin Aspart 70 | Insulin Aspart 70: Patients received biphasic insulin aspart 70 before breakfast and before lunch. | 0 | 20 | 0 | 20 | 2 | 20 |
| EG002 | Insulin Aspart | Insulin Aspart: Patients received insulin aspart before breakfast and before lunch. | 0 | 20 | 0 | 20 | 2 | 20 |
|
| Moderate Hypoglycaemic Event | Endocrine disorders | Moderate Hypo | Systematic Assessment | Hypogylcaemic Event <54mg/dL |
|
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |