Veterans Inpatient Insulin Study and Transition to Outpatient Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: NPH/Regular 70/30 mix; insulin aspart protamine/insulin aspart 70/30 mix
Intervention description: injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration; injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks
Intervention MeSH terms: Insulin; Insulin Aspart; Protamines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; insulin; therapy

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.
    

Eligibility criteria:

        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.