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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wendy Lane MD, Mountain Diabetes and Endocrine Center
ClinicalTrials.gov Identifier:
NCT00606034
First received: January 19, 2008
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Insulin Resistance
Drug: U-500 Insulin delivered by Omnipod (disposable insulin pump)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Mountain Diabetes and Endocrine Center:

Primary Outcome Measures:
  • Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline versus 12 months ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline versus 1 year ] [ Designated as safety issue: No ]
    Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.


Enrollment: 21
Study Start Date: December 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606034

Locations
United States, North Carolina
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States, 28803
Sponsors and Collaborators
Mountain Diabetes and Endocrine Center
Investigators
Principal Investigator: Wendy S Lane, MD Mountain Diabetes and Endocrine Center
  More Information

Publications:
Responsible Party: Wendy Lane MD, Director of Research, Principal Investigator, Mountain Diabetes and Endocrine Center
ClinicalTrials.gov Identifier: NCT00606034     History of Changes
Other Study ID Numbers: U-500R, U500, B5K-US-X009
Study First Received: January 19, 2008
Results First Received: July 26, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mountain Diabetes and Endocrine Center:
Type 2 diabetes
Insulin Resistance
Continuous Subcutaneous Insulin Infusion
U-500 Insulin
Omnipod

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014