Regular Insulin vs Rapid Insulin Delivered by V-Go

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety Comparison Between U-100 Regular Human Insulin and Rapid Acting Insulin When Delivered by VGo Wearable Insulin Delivery in Type 2 Diabetes

Conditions
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Type 2 Diabetes, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: VGo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 years at time of study enrollment Diagnosed with T2D for at least 6 months prior to screening Screening visit A1C ≥ 7.0% and ≤ 12.5% 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 Ability to read and understand English Willing to complete all study related activities 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 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). Completed a 7-point glucose profile prior to Visit 2 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: Subject with confirmed Type 1 diabetes More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry History of hypoglycemia unawareness Require supplemental insulin in addition to V-Go therapy 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. Woman who are lactating. 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 A recipient of a solid organ transplant Current use of U-100 RHI in V-Go within 90 days of screening Current use of U-500 RHI in V-Go within 90 days of screening Currently on dialysis Medical or other problems which in the opinion of the investigator will render study participation unsafe.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VGo with Regular Human Insulin<br>U-100 short-acting insulin, Regular, human insulin rDNA origin, including Humulin® R, Novolin® R, and ReliOn (Novolin R) delivered by V-Go | Device: VGo<br>* 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.<br>|
| Active Comparator: VGo with Rapid Acting Insulin<br>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 | Device: VGo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VGo, Insulin, Type 2 Diabetes