Trial Outcomes & Findings for Regular Insulin vs Rapid Insulin Delivered by V-Go (NCT NCT03495908)
NCT ID: NCT03495908
Last Updated: 2021-03-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-03-02
Participant Flow
Participant milestones
| Measure |
VGo With Regular Human Insulin
Switch to U-100 Regular Human Insulin (RHI) delivered by the V-Go insulin delivery device.
|
VGo With Rapid Acting Insulin
Continue on U-100 Rapid Acting Insulin (RAI) delivered by the V-Go insulin delivery device.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
67
|
|
Overall Study
COMPLETED
|
59
|
54
|
|
Overall Study
NOT COMPLETED
|
10
|
13
|
Reasons for withdrawal
| Measure |
VGo With Regular Human Insulin
Switch to U-100 Regular Human Insulin (RHI) delivered by the V-Go insulin delivery device.
|
VGo With Rapid Acting Insulin
Continue on U-100 Rapid Acting Insulin (RAI) delivered by the V-Go insulin delivery device.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
4
|
|
Overall Study
No documented reason
|
0
|
2
|
Baseline Characteristics
Regular Insulin vs Rapid Insulin Delivered by V-Go
Baseline characteristics by cohort
| Measure |
VGo With Regular Human Insulin
n=69 Participants
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.
|
VGo With Rapid Acting Insulin
n=67 Participants
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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
67 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Hemoglobin A1c
|
8.5 percentage of Hemoglobin A1c
STANDARD_DEVIATION 1.4 • n=5 Participants
|
8.5 percentage of Hemoglobin A1c
STANDARD_DEVIATION 1.5 • n=7 Participants
|
8.5 percentage of Hemoglobin A1c
STANDARD_DEVIATION 1.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Per protocol
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.
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=59 Participants
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.
|
VGo With Rapid Acting Insulin
n=54 Participants
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.
|
|---|---|---|
|
Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.
|
-0.5966 percent
Interval -0.9041 to -0.2892
|
-0.3759 percent
Interval -0.6973 to -0.05455
|
SECONDARY outcome
Timeframe: Baseline and Week 12Number of participants reporting 7-Point Hypoglycemia based on 7-point glucose profiles. Intent-to-treat (ITT) Population N=136
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=69 Participants
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.
|
VGo With Rapid Acting Insulin
n=67 Participants
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.
|
|---|---|---|
|
Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Pre-randomization
|
9 Participants
|
8 Participants
|
|
Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Post-randomization
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-treat safety population, n=136
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.
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=69 Participants
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.
|
VGo With Rapid Acting Insulin
n=67 Participants
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.
|
|---|---|---|
|
Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Pre-randomization
|
0.069 Events per person weeks
|
0.065 Events per person weeks
|
|
Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
Post-randomization
|
0.016 Events per person weeks
|
0.017 Events per person weeks
|
SECONDARY outcome
Timeframe: Baseline and Week 12Between group differences in Insulin TDD U/day. Intent-to-treat Population, n=136
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=69 Participants
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.
|
VGo With Rapid Acting Insulin
n=67 Participants
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.
|
|---|---|---|
|
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
Interval 0.61 to 0.69
|
0.65 units/kg
Interval 0.61 to 0.69
|
|
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
Interval 0.62 to 0.7
|
0.67 units/kg
Interval 0.61 to 0.71
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-treat Population N=136
RHI versus RAI, comparing the change in total daily dose (TDD), units/day of insulin between groups. Intent-to-treat Population N=136
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=69 Participants
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.
|
VGo With Rapid Acting Insulin
n=67 Participants
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.
|
|---|---|---|
|
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
Interval 57.66 to 64.6
|
60.90 units/day
Interval 57.37 to 64.42
|
|
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
Interval 58.38 to 65.41
|
62.74 units/day
Interval 59.15 to 66.32
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Per-protocol population, n=113
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
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=59 Participants
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.
|
VGo With Rapid Acting Insulin
n=54 Participants
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.
|
|---|---|---|
|
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
|
518.31 US dollar
Standard Deviation 124.23
|
|
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
|
533.66 US dollar
Standard Deviation 118.51
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI
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.
Outcome measures
| Measure |
VGo With Regular Human Insulin
n=69 Participants
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.
|
VGo With Rapid Acting Insulin
n=67 Participants
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.
|
|---|---|---|
|
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
Interval -0.8618 to -0.2349
|
-0.4167 percentage of Hemoglobin A1c
Interval -0.7425 to -0.09088
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 12Evaluate the change between baseline and week 12 in glucose patterns between groups based on 7-point glucose profiles.
Outcome measures
Outcome data not reported
Adverse Events
VGo With Regular Human Insulin
Serious events: 5 serious events
Other events: 1 other events
Deaths: 1 deaths
VGo With Rapid Acting Insulin
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VGo With Regular Human Insulin
n=69 participants at risk
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.
|
VGo With Rapid Acting Insulin
n=67 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Heart Attack
|
0.00%
0/69 • 12 weeks. From randomization to end of study.
|
1.5%
1/67 • Number of events 1 • 12 weeks. From randomization to end of study.
|
|
Infections and infestations
Wound
|
0.00%
0/69 • 12 weeks. From randomization to end of study.
|
1.5%
1/67 • Number of events 1 • 12 weeks. From randomization to end of study.
|
|
Gastrointestinal disorders
Colonic perforation
|
1.4%
1/69 • Number of events 1 • 12 weeks. From randomization to end of study.
|
0.00%
0/67 • 12 weeks. From randomization to end of study.
|
|
Cardiac disorders
Worsening of A-fib
|
1.4%
1/69 • Number of events 1 • 12 weeks. From randomization to end of study.
|
0.00%
0/67 • 12 weeks. From randomization to end of study.
|
|
Endocrine disorders
Bilateral Papillary Carcinoma
|
1.4%
1/69 • Number of events 1 • 12 weeks. From randomization to end of study.
|
0.00%
0/67 • 12 weeks. From randomization to end of study.
|
|
Cardiac disorders
Worsening of CHF
|
2.9%
2/69 • Number of events 2 • 12 weeks. From randomization to end of study.
|
0.00%
0/67 • 12 weeks. From randomization to end of study.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/69 • 12 weeks. From randomization to end of study.
|
1.5%
1/67 • Number of events 1 • 12 weeks. From randomization to end of study.
|
Other adverse events
| Measure |
VGo With Regular Human Insulin
n=69 participants at risk
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.
|
VGo With Rapid Acting Insulin
n=67 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Upset stomach
|
1.4%
1/69 • Number of events 1 • 12 weeks. From randomization to end of study.
|
0.00%
0/67 • 12 weeks. From randomization to end of study.
|
|
Product Issues
Skin irritation, welt
|
0.00%
0/69 • 12 weeks. From randomization to end of study.
|
3.0%
2/67 • Number of events 2 • 12 weeks. From randomization to end of study.
|
Additional Information
Dr Pablo F Mora
The University of Texas Southwestern Medical Center
Phone: 469-585-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place