Type 2 Diabetes, Type 2 Diabetes Mellitus
Conditions
Keywords
VGo, Insulin, Type 2 Diabetes
Brief summary
The purpose of the study is to collect data about how well U-100 Regular Human Insulin can be used in the V-Go Insulin Delivery Device compared to U-100 Rapid Acting Insulin in the V-Go Insulin Delivery Device. The data collected will be used to see how much subjects' blood sugar levels change over time after they switch from using U-100 Rapid Acting Insulin to U-100 Regular Human Insulin within their V-Go Insulin Delivery Device.
Interventions
DEVICEVGo
Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
Sponsors
Valeritas, Inc.
Dallas Diabetes Research
East Coast Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 years at time of study enrollment 2. Diagnosed with T2D for at least 6 months prior to screening 3. Screening visit A1C ≥ 7.0% and ≤ 12.5% 4. Prescribed a stable (less than 20% change in the past 30 days) of rapid acting U-100 insulin delivered via V-Go insulin delivery device 5. Ability to read and understand English 6. Willing to complete all study related activities 7. Willing and able to understand and sign a written ICF indicating that they agree to participate and have been informed of all pertinent aspects of the study 8. Must be willing to take and record 7 glucose measurements per time period (pre-morning meal (fasting), pre-midday meal, pre-evening meal, and 2-hours after the start of the morning, midday, and evening meals, and at bedtime) three times throughout the study (prior to Visit 2, 3, and 4). 9. Completed a 7-point glucose profile prior to Visit 2 10. Able (by insurance or financial means) to cover the initial investment and ongoing cost of the V-Go insulin delivery device, insulin (current rapid acting insulin or potential new regular human insulin), personal glucometer and supplies for the length of the study.
Exclusion criteria
1. Subject with confirmed Type 1 diabetes 2. More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry 3. History of hypoglycemia unawareness 4. Require supplemental insulin in addition to V-Go therapy 5. Woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study. Women of childbearing potential are defined as any female who has experienced menarche and who it NOT permanently sterile of postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without and alternative medical cause. 6. Woman who are lactating. 7. Use of any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study 8. A recipient of a solid organ transplant 9. Current use of U-100 RHI in V-Go within 90 days of screening 10. Current use of U-500 RHI in V-Go within 90 days of screening 11. Currently on dialysis 12. Medical or other problems which in the opinion of the investigator will render study participation unsafe.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis. | Baseline and Week 12 | Per protocol population for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Baseline and Week 12 | Number of participants reporting 7-Point Hypoglycemia based on 7-point glucose profiles. Intent-to-treat (ITT) Population N=136 |
| Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Baseline and Week 12 | Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group. |
| Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment. | Baseline and Week 12 | Between group differences in Insulin TDD U/day. Intent-to-treat Population, n=136 |
| Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups. | Baseline and Week 12 | Cost Analysis for direct diabetes-related pharmacy insulin costs. All insulin costs are normalized to 30-days and based on the prescribed TDD at V2 (Baseline) and at study end (EOS) and multiplying the insulin dose in units by the average unit cost of the prescribed insulin |
| Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis. | Baseline and Week 12 | Intent-to-treat population secondary outcome for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference. |
| Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment. | Baseline and Week 12 | RHI versus RAI, comparing the change in total daily dose (TDD), units/day of insulin between groups. Intent-to-treat Population N=136 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Change in Glucose Patterns Between Groups Based on 7-point Glucose Profiles. | Baseline and Week 12 | Evaluate the change between baseline and week 12 in glucose patterns between groups based on 7-point glucose profiles. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VGo With Regular Human Insulin VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go. | 69 |
| VGo With Rapid Acting Insulin VGo: Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go. | 67 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | No documented reason | 0 | 2 |
| Overall Study | Physician Decision | 5 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | VGo With Regular Human Insulin | Total | VGo With Rapid Acting Insulin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 53 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 83 Participants | 42 Participants |
| Age, Continuous | 65.2 years STANDARD_DEVIATION 10.9 | 61.3 years STANDARD_DEVIATION 11.3 | 60.2 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 132 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c | 8.5 percentage of Hemoglobin A1c STANDARD_DEVIATION 1.4 | 8.5 percentage of Hemoglobin A1c STANDARD_DEVIATION 1.4 | 8.5 percentage of Hemoglobin A1c STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 50 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 47 Participants | 82 Participants | 35 Participants |
| Region of Enrollment United States | 69 participants | 136 participants | 67 participants |
| Sex: Female, Male Female | 39 Participants | 82 Participants | 43 Participants |
| Sex: Female, Male Male | 30 Participants | 54 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 69 | 0 / 67 |
| other Total, other adverse events | 1 / 69 | 2 / 67 |
| serious Total, serious adverse events | 5 / 69 | 3 / 67 |
Outcome results
Primary
Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.
Per protocol population for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference.
Time frame: Baseline and Week 12
Population: Per protocol
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis. | -0.5966 percent |
| VGo With Rapid Acting Insulin | Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis. | -0.3759 percent |
Comparison: RHI - RAI estimated treatment difference (ETD) in HbA1c. Per-protocol analysis is the pre-specified primary outcome.p-value: 0.00795% CI: [-0.6654, 0.2241]Mixed Models Analysis
Secondary
Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis.
Intent-to-treat population secondary outcome for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference.
Time frame: Baseline and Week 12
Population: Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis. | -0.5484 percentage of Hemoglobin A1c |
| VGo With Rapid Acting Insulin | Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis. | -0.4167 percentage of Hemoglobin A1c |
Comparison: Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAIp-value: 0.0295% CI: [-0.5838, 0.3205]Mixed Models Analysis
Secondary
Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment.
RHI versus RAI, comparing the change in total daily dose (TDD), units/day of insulin between groups. Intent-to-treat Population N=136
Time frame: Baseline and Week 12
Population: Intent-to-treat Population N=136
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment. | Baseline Insulin TDD, U/day | 61.13 units/day |
| VGo With Regular Human Insulin | Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment. | End of Study Insulin TDD, U/day | 61.90 units/day |
| VGo With Rapid Acting Insulin | Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment. | Baseline Insulin TDD, U/day | 60.90 units/day |
| VGo With Rapid Acting Insulin | Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment. | End of Study Insulin TDD, U/day | 62.74 units/day |
p-value: 0.3295% CI: [-3.2139, 1.0587]Mixed Models Analysis
Secondary
Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment.
Between group differences in Insulin TDD U/day. Intent-to-treat Population, n=136
Time frame: Baseline and Week 12
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment. | End of study TDD U/kg | 0.66 units/kg |
| VGo With Regular Human Insulin | Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment. | Baseline TDD U/kg | 0.65 units/kg |
| VGo With Rapid Acting Insulin | Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment. | Baseline TDD U/kg | 0.65 units/kg |
| VGo With Rapid Acting Insulin | Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment. | End of study TDD U/kg | 0.67 units/kg |
Comparison: RHI versus RAI for Insulin Intent-to-treat Population N=136 Mixed Model Estimates for Insulin TDD U/kg Ip-value: 0.41595% CI: [-0.03674, 0.01528]Mixed Models Analysis
Secondary
Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups.
Cost Analysis for direct diabetes-related pharmacy insulin costs. All insulin costs are normalized to 30-days and based on the prescribed TDD at V2 (Baseline) and at study end (EOS) and multiplying the insulin dose in units by the average unit cost of the prescribed insulin
Time frame: Baseline and Week 12
Population: Per-protocol population, n=113
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups. | Baseline Insulin Cost, $ | 515.68 US dollar | Standard Deviation 123.01 |
| VGo With Regular Human Insulin | Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups. | End of Study Insulin Cost, $ | 265.19 US dollar | Standard Deviation 61.39 |
| VGo With Rapid Acting Insulin | Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups. | Baseline Insulin Cost, $ | 518.31 US dollar | Standard Deviation 124.23 |
| VGo With Rapid Acting Insulin | Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups. | End of Study Insulin Cost, $ | 533.66 US dollar | Standard Deviation 118.51 |
p-value: <0.000195% CI: [-288.6, -243.11]Mixed Models Analysis
Secondary
Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.
Time frame: Baseline and Week 12
Population: Intent-to-treat safety population, n=136
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Pre-randomization | 0.069 Events per person weeks |
| VGo With Regular Human Insulin | Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Post-randomization | 0.016 Events per person weeks |
| VGo With Rapid Acting Insulin | Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Pre-randomization | 0.065 Events per person weeks |
| VGo With Rapid Acting Insulin | Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Post-randomization | 0.017 Events per person weeks |
Comparison: Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.p-value: 0.86195% CI: [0.386, 2.217]Regression, Poisson
Secondary
Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Number of participants reporting 7-Point Hypoglycemia based on 7-point glucose profiles. Intent-to-treat (ITT) Population N=136
Time frame: Baseline and Week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| VGo With Regular Human Insulin | Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Pre-randomization | 9 Participants |
| VGo With Regular Human Insulin | Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Post-randomization | 11 Participants |
| VGo With Rapid Acting Insulin | Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Pre-randomization | 8 Participants |
| VGo With Rapid Acting Insulin | Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. | Post-randomization | 12 Participants |
Comparison: Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.p-value: 0.82Fisher Exact
Other Pre-specified
Evaluate the Change in Glucose Patterns Between Groups Based on 7-point Glucose Profiles.
Evaluate the change between baseline and week 12 in glucose patterns between groups based on 7-point glucose profiles.
Time frame: Baseline and Week 12