Expired Study
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Asheville, North Carolina 28803


Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using nonconcentrated forms of insulin (U100 insulin formulations) will be able to control their blood glucose levels using 5X concentrated insulin (U500 regular insulin) when it is infused continuously subcutaneously via insulin pump.

Study summary:

Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. In these patients, using a concentrated form of insulin called U-500 Regular insulin and and delivering it by continuous subcutaneous infusion via insulin pump lowers the volume of insulin required which improves absorption and leads to improved blood glucose control.


Inclusion Criteria: - Type 2 diabetes on stable insulin regimen with or without oral agents for at least 3 months - HbA1c > 7% - No significant cardiovascular, renal or other serious medical diseases Exclusion Criteria: - HbA1c < 7% - Chronic renal, hepatic, cardiovascular, or other serious medical illness - Females of childbearing age not using adequate contraception - Use of GLP mimetic



Primary Contact:

Principal Investigator
Wendy S Lane, MD
Mountain Diabetes and Endocrine Center

Backup Contact:


Location Contact:

Asheville, North Carolina 28803
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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