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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606034
• Other study ID #: U-500R
• Secondary ID: U500B5K-US-X009
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2008
• Last updated: January 7, 2014
• Start date: December 2007
• Est. completion date: July 2009

Study information

• Verified date: January 2014
• Source: Mountain Diabetes and Endocrine Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mountain Diabetes and Endocrine Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lane WS. Use of U-500 regular insulin by continuous subcutaneous insulin infusion in patients with type 2 diabetes and severe insulin resistance. Endocr Pract. 2006 May-Jun;12(3):251-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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.	baseline versus 12 months	Yes
Secondary	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.	Baseline versus 1 year	No