Veterans Inpatient Insulin Study and Transition to Outpatient Therapy

Study Overview
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Brief Summary
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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: To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.

Detailed Description
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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.

Official Title
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Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: NPH/Regular 70/30 mix
* Drug: insulin aspart protamine/insulin aspart 70/30 mix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes for duration of three-months or longer greater than or equal to 40 years of age Written informed consent to participate in the study Admitted for hospitalization at VA Medical Center Lexington, KY Able and willing to do the following: Use the insulin injection device provided to you as you are instructed Check your blood sugar as instructed using the blood sugar monitor and send the results by a glucose log or a telephone transmitter provided to you for use during the study Enter your information in a diary provided to you You have an acute non-critical medical illness requiring inpatient hospitalization (at least 24 hour admission) with a blood glucose between 140 and 400 mg/dl. You require further hospitalization after being released from intensive care unit for an acute illness Exclusion Criteria: Have developed a severe illness requiring treatment in an intensive care unit as determined by your admitting physician. Are pregnant or intend to become pregnant during this study, or are a sexually active woman who could become pregnant and are not practicing a birth control method considered acceptable by your study doctor for preventing pregnancy. Are a woman who is breastfeeding. Have a history of heart disease that limits your physical activity Have had a kidney transplant or are currently receiving kidney dialysis Have history of cancer other than minor skin cancer. Have had a blood transfusion or severe loss of blood in the past 3 months or have any disease of the blood system. Are allergic or sensitive to study insulin. Are currently receiving oral steroid therapy. Are currently on any other investigational medications or investigational protocols Have drug or alcohol abuse that in the investigator's opinion would cause the individual to be non-compliant. Are poorly compliant with the currently prescribed diabetes regimen or self monitoring of blood glucose, as defined by the investigator. Have a mental condition that renders you unable to understand the scope and possible consequences of the study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NPH/Regular 70/30 mix<br>transition insulin therapy with NPH/Regular 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness | Drug: NPH/Regular 70/30 mix<br>* injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration<br>* Other names: Novolin 70/30;|
| Active Comparator: Aspart insulin analog biphasic mix<br>transition insulin therapy with Aspart insulin analog 70/30 mix for outpatient glycemic control following a hospitalization for non-critical acute illness | Drug: insulin aspart protamine/insulin aspart 70/30 mix<br>* injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks<br>* Other names: Novolog Mix 70/30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Hypoglycemia |  | daily | 
| Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter |  | daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, insulin, therapy