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Regular Insulin vs Rapid Insulin Delivered by V-Go

Primary Purpose

Type 2 Diabetes, Type 2 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VGo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring VGo, Insulin, Type 2 Diabetes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

East Coast Institute for Research, LLC
East Coast Institute for Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VGo with Regular Human Insulin

VGo with Rapid Acting Insulin

Arm Description

U-100 short-acting insulin, Regular, human insulin rDNA origin, including Humulin® R, Novolin® R, and ReliOn (Novolin R) delivered by V-Go

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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

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

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

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.

Full Information

NCT ID

NCT03495908

First Posted

March 17, 2018

Last Updated

February 10, 2021

Sponsor

East Coast Institute for Research

Collaborators

Valeritas, Inc., Dallas Diabetes Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03495908

Brief Title

Regular Insulin vs Rapid Insulin Delivered by V-Go

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

April 9, 2018 (Actual)

Primary Completion Date

August 12, 2019 (Actual)

Study Completion Date

August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

East Coast Institute for Research

Collaborators

Valeritas, Inc., Dallas Diabetes Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Type 2 Diabetes Mellitus

Keywords

VGo, Insulin, Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VGo with Regular Human Insulin

Arm Type

Experimental

Arm Description

U-100 short-acting insulin, Regular, human insulin rDNA origin, including Humulin® R, Novolin® R, and ReliOn (Novolin R) delivered by V-Go

Arm Title

VGo with Rapid Acting Insulin

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

VGo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.

Description

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

Secondary Outcome Measure Information:

Title

Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.

Description

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

Title

Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.

Description

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

Title

Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment.

Description

Between group differences in Insulin TDD U/day. Intent-to-treat Population, n=136

Time Frame

Baseline and Week 12

Title

Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment.

Description

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

Title

Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups.

Description

Time Frame

Baseline and Week 12

Title

Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis.

Description

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

Other Pre-specified Outcome Measures:

Title

Evaluate the Change in Glucose Patterns Between Groups Based on 7-point Glucose Profiles.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

East Coast Institute for Research, LLC

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

East Coast Institute for Research, LLC

City

Macon

State/Province

Georgia

ZIP/Postal Code

31210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33214190

Citation

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.

Results Reference

derived

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Regular Insulin vs Rapid Insulin Delivered by V-Go

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