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Veterans Inpatient Insulin Study and Transition to Outpatient Therapy (VIISTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821795
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Dennis G. Karounos, M.D., Lexington VA Medical Center

Tracking Information
First Submitted Date  ICMJE January 12, 2009
First Posted Date  ICMJE January 13, 2009
Results First Submitted Date  ICMJE February 19, 2020
Results First Posted Date  ICMJE March 4, 2020
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE March 11, 2009
Actual Primary Completion Date April 23, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • Seven Point Blood Glucose Profiles [ Time Frame: 2 weeks ]
    mg/dl
  • Patient-reported Outcomes - Diabetes Symptom Checklist to Evaluate Perception of Diabetes Control [ Time Frame: 16 weeks ]
  • Hypoglycemia [ Time Frame: daily ]
  • Twice Daily Blood Glucose Monitoring Using Telehealth Transmitter [ Time Frame: daily ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
  • Seven point blood glucose profiles [ Time Frame: 2 weeks ]
  • Patient-reported outcomes - diabetes symptom checklist to evaluate perception of diabetes control [ Time Frame: 16 weeks ]
  • Hypoglycemia [ Time Frame: daily ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Official Title  ICMJE Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy
Brief Summary

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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: NPH/Regular 70/30 mix
    injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration
    Other Name: Novolin 70/30
  • Drug: 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
    Other Name: Novolog Mix 70/30
Study Arms  ICMJE
  • 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
    Intervention: Drug: NPH/Regular 70/30 mix
  • 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
    Intervention: Drug: insulin aspart protamine/insulin aspart 70/30 mix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 23, 2013
Actual Primary Completion Date April 23, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821795
Other Study ID Numbers  ICMJE VIISTA-596-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dennis G. Karounos, M.D., Lexington VA Medical Center
Original Responsible Party Dennis G. Karounos, M.D., VA Medical Center Lexington, KY
Current Study Sponsor  ICMJE Dennis G. Karounos, M.D.
Original Study Sponsor  ICMJE Lexington VA Medical Center
Collaborators  ICMJE Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Dennis G Karounos, MD VA Medical Center Lexington, KY and University of Kentucky College of Medicine
PRS Account Lexington VA Medical Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP