Insulin Resistance, Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Insulin Resistance, Continuous Subcutaneous Insulin Infusion, U-500 Insulin, Omnipod
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.
Interventions
DRUGU-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
Sponsors
Mountain Diabetes and Endocrine Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Spent in Hypoglycemia | 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. |
| Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited between Dec 2008 and Dec 2009 from clinic at Mountain Diabetes and Endocrine Center.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | incarceration | 1 |
Baseline characteristics
| Characteristic | All Subjects Active |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 53.86 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
Primary
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.
Time frame: 1 year
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects Using U-500 Regular Insulin Via Omnipod | Improvement in Glycemic Control as Assessed by Change in Hemoglobin A1c (HbA1c) | -1.23 HbA1c percentage | Standard Deviation 1.03 |
Secondary
Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ)
Overall satisfaction rated on a scale of 0-100 percent with higher numbers indicating greater satisfaction with the insulin delivery method.
Time frame: Baseline versus 1 year
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects Using U-500 Regular Insulin Via Omnipod | Patient Satisfaction With Insulin Delivery Method Via Insulin Delivery Rating System Questionnaire (IDRSQ) | 90.68 percent satisfaction | Standard Deviation 8.13 |
Secondary
Percentage of Time Spent in Hypoglycemia
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.
Time frame: baseline versus 12 months
Population: ITT (LOCF for 1 subject)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects Using U-500 Regular Insulin Via Omnipod | Percentage of Time Spent in Hypoglycemia | -3.7 percent of time spent in hypoglycemia | Standard Deviation 4.8 |