PK/PD Study of U-500 Regular Insulin
Condition: Type 2 Diabetes; Insulin Resistance; High Insulin Requirements
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance; Hyperinsulinism
Intervention: U-500 insulin, 100 syringe units; U-500 insulin, 200 syringe units
Intervention description: Subjects are randomized to receive 100 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.; Subjects are randomized to receive 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 diabetes; Insulin resistance; High insulin requirements; U 500

Summary:

      The purpose of this study is to learn more about how U500 regular insulin can be effectively
      be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take
      U100 insulin, but if they require large doses (such as >150 units a day) they may experience
      pain at this site of injection and the absorption of the insulin is unpredictable, thereby
      leading to poor glucose control. To overcome these problems, doctors sometimes switch to a
      more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as
      U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume.
      However, how to best use U-500 insulin is not certain. The investigators are not really sure
      how long a given dose is effective in patients who require large doses (>150 units of U100
      insulin), so are not sure of how often the drug should be administered. In this study, the
      investigators will determine how effective two different doses of U-500 regular insulin (100
      U and 200 U) are in lowering blood sugar and how long these two doses last. This information
      will help doctors develop better treatment plans for patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Ages 30-65 years

          -  A1c between 7-9.5% within the past month

          -  On >100 units of insulin per day

          -  Willing to discontinue oral/injectable non-insulin hypoglycemic agents for minimum of
             1 week prior to study

          -  Willing to avoid exercise 48 hours prior to study

          -  Willing to be fasting for up to 24 hours

          -  BMI between 25 and 38 kg/m2

        Exclusion Criteria:

          -  • On systemic corticosteroids in preceding 3 months

               -  Heavy alcohol consumption (>21 drinks/week men, >14 drinks/week women)

               -  Unwillingness to stop alcohol consumption for 24 hours before each study visit

               -  Pregnant or actively trying to conceive

               -  Current diagnosis of active infection, cancer (other than basal cell carcinoma),
                  vascular disease, organ failure

               -  Current transplant recipient