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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Lexington VA Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novo Nordisk
Information provided by:
Lexington VA Medical Center
ClinicalTrials.gov Identifier:
NCT00821795
First received: January 12, 2009
Last updated: February 27, 2009
Last verified: February 2009
History of Changes
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: NPH/Regular 70/30 mix
Drug: insulin aspart protamine/insulin aspart 70/30 mix
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lexington VA Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seven point blood glucose profiles [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Patient-reported outcomes - diabetes symptom checklist to evaluate perception of diabetes control [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Hypoglycemia [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • twice daily blood glucose monitoring using telehealth transmitter [ Time Frame: daily ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for duration of three-months or longer
  • 40-75 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821795

Contacts
Contact: Linda S Barber, RN, BSN (859)233-4511 ext 4427 linda.barber2@va.gov
Contact: Janet Hibbard, BS (859)233-4511 ext 4611 jhibb2@uky.edu

Locations
United States, Kentucky
VA Medical Center - Lexington 596 Recruiting
Lexington, Kentucky, United States, 40502
Contact: Linda S Barber, RN, BSN     859-233-4511 ext 4427     linda.barber2@va.gov    
Contact: Janet Hibbard, BS     (859)233-4511 ext 4611     jhibb2@uky.edu    
Principal Investigator: Dennis G Karounos, MD            
Sponsors and Collaborators
Lexington VA Medical Center
Novo Nordisk
Investigators
Principal Investigator: Dennis G Karounos, MD VA Medical Center Lexington, KY and University of Kentucky College of Medicine
  More Information

No publications provided

Responsible Party: Dennis G. Karounos, M.D., VA Medical Center Lexington, KY
ClinicalTrials.gov Identifier: NCT00821795     History of Changes
Other Study ID Numbers: VIISTA-596-1
Study First Received: January 12, 2009
Last Updated: February 27, 2009
Health Authority: United States: Federal Government

Keywords provided by Lexington VA Medical Center:
Diabetes Mellitus, Type 2
insulin
therapy

Additional relevant MeSH terms:
Insulin aspart
Insulin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Protamines
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013