- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00821795
Veterans Inpatient Insulin Study and Transition to Outpatient Therapy (VIISTA)
Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40502
- VA Medical Center - Lexington 596
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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
|
injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
Other Names:
|
ACTIVE_COMPARATOR: 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
|
injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks
Other Names:
|
What is the study measuring?
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.
Time Frame: 16 weeks
|
Hemoglobin A1c
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seven Point Blood Glucose Profiles
Time Frame: 2 weeks
|
mg/dl
|
2 weeks
|
Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control
Time Frame: 16 weeks
|
16 weeks
|
|
Hypoglycemia
Time Frame: daily
|
daily
|
|
Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter
Time Frame: daily
|
daily
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dennis G Karounos, MD, VA Medical Center Lexington, KY and University of Kentucky College of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIISTA-596-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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