Trial Outcomes & Findings for U-500R Insulin In Type 2 Diabetes With Severe Insulin Resistance Via Omnipod (NCT NCT00606034)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

1 year

Results posted on

2014-02-06

Participant Flow

Subjects recruited between Dec 2008 and Dec 2009 from clinic at Mountain Diabetes and Endocrine Center.

Patients who had failed any previous insulin regimen with HbA1c over 7% and requiring over 100 units of insulin per day were enrolled and switched to treatment with U500 insulin via Omnipod.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study incarceration	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects Active n=21 Participants All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	53.86 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Per Protocol

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.

Outcome measures

Outcome measures
Measure	All Subjects Using U-500 Regular Insulin Via Omnipod n=21 Participants All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c)	-1.23 HbA1c percentage Standard Deviation 1.03

SECONDARY outcome

Timeframe: baseline versus 12 months

Population: ITT (LOCF for 1 subject)

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.

Outcome measures

Outcome measures
Measure	All Subjects Using U-500 Regular Insulin Via Omnipod n=21 Participants All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Percentage of Time Spent in Hypoglycemia	-3.7 percent of time spent in hypoglycemia Standard Deviation 4.8

SECONDARY outcome

Timeframe: Baseline versus 1 year

Population: per protocol

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

Outcome measures

Outcome measures
Measure	All Subjects Using U-500 Regular Insulin Via Omnipod n=21 Participants All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)	90.68 percent satisfaction Standard Deviation 8.13

Adverse Events

All Subjects Active

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects Active n=21 participants at risk All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
Endocrine disorders Hypoglycemia	4.8% 1/21 • Number of events 1 • 1 Year Subjects will be assessed for adverse events at each study visit and will report serious adverse events via the 24 hour contact number.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wendy Lane, Director of Clinical Research

Mountain Diabetes and Endocrine Center

Phone: 828-258-2404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place