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

NCT ID: NCT00606034

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-07-31

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.

Conditions

Type 2 Diabetes; Insulin Resistance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mountain Diabetes and Endocrine Center

OTHER

Sponsor Role: lead

Responsible Party

Wendy Lane MD

Director of Research, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy S Lane, MD

Role: PRINCIPAL_INVESTIGATOR

Mountain Diabetes and Endocrine Center

Locations

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16772195 (View on PubMed)

Other Identifiers

U500

Identifier Type: -

Identifier Source: secondary_id

B5K-US-X009

Identifier Type: -

Identifier Source: secondary_id

U-500R

Identifier Type: -

Identifier Source: org_study_id