NCT00606034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

December 30, 2013

Completed
Last Updated

February 6, 2014

Status Verified

January 1, 2014

Enrollment Period

1.6 years

First QC Date

January 19, 2008

Results QC Date

July 26, 2012

Last Update Submit

January 7, 2014

Conditions

Type 2 DiabetesInsulin Resistance

Keywords

Type 2 diabetesInsulin ResistanceContinuous Subcutaneous Insulin InfusionU-500 InsulinOmnipod

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Percentage of Time Spent in Hypoglycemia

    baseline versus 12 months

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

    Baseline versus 1 year

Study Arms (1)

All subjects active

EXPERIMENTAL

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)

Interventions

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

All subjects active

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • HbA1c \< 7%
  • Chronic renal, hepatic, cardiovascular, or other serious medical illness
  • Females of childbearing age not using adequate contraception
  • Use of GLP mimetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

Related 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. doi: 10.4158/EP.12.3.251.

    PMID: 16772195BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Limitations and Caveats

Small sample size. Also an uncontrolled pilot study.

Results Point of Contact

Title
Dr. Wendy Lane, Director of Clinical Research
Organization
Mountain Diabetes and Endocrine Center
mountaindiabetes@msn.com
828-258-2404

Study Officials

  • Wendy S Lane, MD

    Mountain Diabetes and Endocrine Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Principal Investigator

Study Record Dates

First Submitted

January 19, 2008

First Posted

February 1, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

February 6, 2014

Results First Posted

December 30, 2013

Record last verified: 2014-01

Locations

US(1)