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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions:
By doing this study, we hope to learn the optimal way to use insulin therapy to treat individuals during a hospitalization for an illness as well as during the recovery phase of the illness for twenty-four weeks after discharge from the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPH/Regular 70/30 mix | Active Comparator | transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness |
|
| Aspart insulin analog biphasic mix | Active Comparator | transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPH/Regular 70/30 mix | Drug | injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase. | Hemoglobin A1c | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seven Point Blood Glucose Profiles | mg/dl | 2 weeks |
| Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis G Karounos, MD | VA Medical Center Lexington, KY and University of Kentucky College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center - Lexington 596 | Lexington | Kentucky | 40502 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPH/Regular 70/30 Mix | transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration |
| FG001 | Aspart Insulin Analog Biphasic Mix | transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NPH/Regular 70/30 Mix | transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration |
| BG001 |
| 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 | For Transition From Inpatient to Outpatient Care, Evaluate Glycemic Control in Subjects Randomized to Receive 70/30 NPH/Regular Insulin or Aspart Analog 70/30 Mix Bid- Main Outcome Will be HbA1c During Transition Outpatient Therapy Phase. | Hemoglobin A1c | Posted | Mean | Standard Deviation | % hemoglobin A1c | 16 weeks |
|
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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 | NPH/Regular 70/30 Mix | transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness NPH/Regular 70/30 mix: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular disease | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
The study is confined to Veterans requiring hospital admission for an acute medical illness on a general medicine ward with our study population being predominately elderly males greater than sixty years of age.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis G Karounos, MD Principal investigator | Lexington VAMC | 859 233-4511 | 4430 | dennis.karounos@va.gov |
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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 |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
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| insulin aspart protamine/insulin aspart 70/30 mix | Drug | injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks |
|
|
| Hypoglycemia | daily |
| Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter | daily |
| Aspart Insulin Analog Biphasic Mix |
transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Seven Point Blood Glucose Profiles | mg/dl | Not Posted | 2 weeks | Participants |
| Secondary | Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control | Not Posted | 16 weeks | Participants |
| Secondary | Hypoglycemia | Not Posted | daily | Participants |
| Secondary | Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter | Not Posted | daily | Participants |
| 15 |
| 50 |
| 6 |
| 50 |
| EG001 | Aspart Insulin Analog Biphasic Mix | transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness insulin aspart protamine/insulin aspart 70/30 mix: injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks | 10 | 64 | 9 | 64 |
| Cerebral vascular disease | Vascular disorders |
|
| Gastrointestinal | Gastrointestinal disorders |
|
| Genitourinary | Renal and urinary disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Neurological disease | Nervous system disorders | Non-systematic Assessment |
|
| Pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Adverse reaction | General disorders | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |