U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens
  • Phase

    Phase 4
  • Study Type

  • Intervention/Treatment

    insulin human ...
  • Study Participants

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.
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.
Study Started
Dec 31
Primary Completion
Jul 31
Study Completion
Jul 31
Results Posted
Dec 30
Last Update
Feb 06

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

U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs

All subjects active Experimental

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


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


All Subjects Active

All Events

Event Type Organ System Event Term All Subjects Active

Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)

HbA1c is expressed as a percentage. This measurement represents an average of plasma glucose concentration for about 3 months. We will report the change in HbA1c measured at 12 months vs Baseline.

All Subjects Using U-500 Regular Insulin Via Omnipod

HbA1c percentage (Mean)
Standard Deviation: 1.03

Percentage of Time Spent in Hypoglycemia

For the purposed of this study, hypoglycemia is defined as a blood glucose measurement of less than 70 mg/dl. As part of of this study, subjects will wear a Continuous Glucose Monitor (CGM) for 72 hours to assess glycemic control. The percent of time in hypoglycemia is a part of the download from the CGM.

All Subjects

percent of time spent in hypoglycemia (Mean)
Standard Deviation: 4.8

Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)

Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.

All Subjects

percent satisfaction (Mean)
Standard Deviation: 8.13

Age, Continuous

years (Mean)
Standard Deviation: 11.2

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

All Subjects Active

Drop/Withdrawal Reasons

All Subjects Active