PK/PD Study of U-500 Regular Insulin

Completed · Phase 2

Conditions studied: Type 2 Diabetes, Insulin Resistance, High Insulin Requirements

In brief

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.

Key facts

Study ID

NCT02148250

Run by

University of Minnesota

People needed

17

Starts

2015-07-01

Expected to finish

2017-12-01

Last updated by the study team

2020-02-26

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• • 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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