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| Name | Class |
|---|---|
| Valeritas, Inc. | INDUSTRY |
| Dallas Diabetes Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VGo with Regular Human Insulin | Experimental | U-100 short-acting insulin, Regular, human insulin rDNA origin, including Humulin® R, Novolin® R, and ReliOn (Novolin R) delivered by V-Go |
|
| VGo with Rapid Acting Insulin | Active Comparator | U-100 fast-acting insulin including Humalog® (insulin lispro, rDNA origin) or NovoLog® (insulin aspart, rDNA origin), which have both been tested by Valeritas, Inc. and found to be safe for use in the V-Go or Apidra® (insulin glulisine, rDNA origin) delivered by V-Go |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VGo | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Week 12 |
| Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32204 | United States | ||
| East Coast Institute for Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33214190 | Derived | Mora PF, Sutton DR, Gore A, Baliga B, Goldfaden RF, Nikkel C, Sink Ii J, Adams-Huet B. Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes. BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001832. doi: 10.1136/bmjdrc-2020-001832. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VGo With Regular Human Insulin | Switch to U-100 Regular Human Insulin (RHI) delivered by the V-Go insulin delivery device. |
| FG001 | VGo With Rapid Acting Insulin | Continue on U-100 Rapid Acting Insulin (RAI) delivered by the V-Go insulin delivery device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | VGo With Rapid Acting Insulin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol | Posted | Least Squares Mean | 95% Confidence Interval | percent | Baseline and Week 12 |
|
12 weeks. From randomization to end of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Attack | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upset stomach | Gastrointestinal disorders | Systematic Assessment | Possibly related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pablo F Mora | The University of Texas Southwestern Medical Center | 469-585-0000 | pf_mora@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2018 | Dec 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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. |
| Baseline and Week 12 |
| 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 | Baseline and Week 12 |
| 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 | Baseline and Week 12 |
| 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 | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| Macon |
| Georgia |
| 31210 |
| United States |
| Adverse Event |
|
| Death |
|
| Physician Decision |
|
| No documented reason |
|
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | percentage of Hemoglobin A1c |
|
|
|
|
| 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 | Posted | Count of Participants | Participants | Baseline and Week 12 |
|
|
|
|
| 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. | Intent-to-treat safety population, n=136 | Posted | Number | Events per person weeks | Baseline and Week 12 |
|
|
|
|
| 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 | Posted | Least Squares Mean | 95% Confidence Interval | units/kg | Baseline and Week 12 |
|
|
|
|
| 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 | Intent-to-treat Population N=136 | Posted | Least Squares Mean | 95% Confidence Interval | units/day | Baseline and Week 12 |
|
|
|
|
| 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 | Per-protocol population, n=113 | Posted | Mean | Standard Deviation | US dollar | Baseline and Week 12 |
|
|
|
|
| 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. | Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI | Posted | Least Squares Mean | 95% Confidence Interval | percentage of Hemoglobin A1c | Baseline and Week 12 |
|
|
|
|
| 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. | Not Posted | Baseline and Week 12 | Participants |
| 1 |
| 69 |
| 5 |
| 69 |
| 1 |
| 69 |
| EG001 | 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. | 0 | 67 | 3 | 67 | 2 | 67 |
| Wound | Infections and infestations | Systematic Assessment |
|
| Colonic perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Worsening of A-fib | Cardiac disorders | Systematic Assessment |
|
| Bilateral Papillary Carcinoma | Endocrine disorders | Systematic Assessment |
|
| Worsening of CHF | Cardiac disorders | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | Systematic Assessment |
|
| Skin irritation, welt | Product Issues | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| Superiority |
Analysis of the 7-point profiles within the ITT population (n=136) |