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

Mountain Diabetes and Endocrine Center

Status and phase: Completed; Phase 4

Conditions: Insulin Resistance; Type 2 Diabetes

Treatments: Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)

Study type: Interventional

Funder types: Other

Identifiers

NCT00606034

U-500R

B5K-US-X009

U500

Details and patient eligibility

About

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.

Full description

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. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

All subjects active

Experimental group

Description:

All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.

Treatment:

Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)