Skip to main content
OpenTrials
Completed

NCT Number: NCT00606034

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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 outcomes

  1. 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

  1. Percentage of Time Spent in Hypoglycemia

    Time frame: baseline versus 12 months

    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.

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

    Time frame: Baseline versus 1 year

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

Sponsors and collaborators

Lead sponsor

Mountain Diabetes and Endocrine Center

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 1, 2008
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.