PK/PD Study of U-500 Regular Insulin

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborator: Eli Lilly and Company
• Treatments: Insulin; Insulin, Globin Zinc

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