U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
Primary Purpose
Type 2 Diabetes, Insulin Resistance
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
U-500 Insulin delivered by Omnipod (disposable insulin pump)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, U-500 Insulin, Omnipod
Eligibility Criteria
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
Sites / Locations
- Mountain Diabetes and Endocrine Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects active
Arm Description
All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT00606034
First Posted
January 19, 2008
Last Updated
January 7, 2014
Sponsor
Mountain Diabetes and Endocrine Center
1. Study Identification
Unique Protocol Identification Number
NCT00606034
Brief Title
U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mountain Diabetes and Endocrine Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Insulin Resistance
Keywords
Type 2 diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, U-500 Insulin, Omnipod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects active
Arm Type
Experimental
Arm Description
All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Intervention Type
Drug
Intervention Name(s)
U-500 Insulin delivered by Omnipod (disposable insulin pump)
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of Time Spent in Hypoglycemia
Description
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.
Time Frame
baseline versus 12 months
Title
Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)
Description
Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.
Time Frame
Baseline versus 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy S Lane, MD
Organizational Affiliation
Mountain Diabetes and Endocrine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mountain Diabetes and Endocrine Center
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16772195
Citation
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. doi: 10.4158/EP.12.3.251.
Results Reference
background
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U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod
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