U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod

Completed · Phase 4

Conditions studied: Type 2 Diabetes, Insulin Resistance

In brief

Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Key facts

Study ID

NCT00606034

Run by

Mountain Diabetes and Endocrine Center

People needed

21

Starts

2007-12-01

Expected to finish

2009-07-01

Last updated by the study team

2014-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• HbA1c < 7%
• Chronic renal, hepatic, cardiovascular, or other serious medical illness
• Females of childbearing age not using adequate contraception
• Use of GLP mimetic

Where it is running

• Mountain Diabetes and Endocrine Center — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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