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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
All subjects active
All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Intervention: U-500 Insulin delivered by Omnipod (disposable insulin pump) (Drug)
Outcomes
Primary Outcomes
Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
Time Frame: 1 year
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.
Secondary Outcomes
- Percentage of Time Spent in Hypoglycemia(baseline versus 12 months)
- Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)(Baseline versus 1 year)
Investigators
Wendy Lane MD
Director of Research, Principal Investigator
Mountain Diabetes and Endocrine Center