Regular Insulin vs Rapid Insulin Delivered by V-Go

NCT ID: NCT03495908

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2019-08-12

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.

Conditions

Type 2 Diabetes; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VGo with Regular Human Insulin

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

Group Type: EXPERIMENTAL

VGo

Intervention Type: 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.

VGo with Rapid Acting Insulin

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

Group Type: ACTIVE_COMPARATOR

VGo

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeritas, Inc.

INDUSTRY

Sponsor Role: collaborator

Dallas Diabetes Research

OTHER

Sponsor Role: collaborator

East Coast Institute for Research

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

East Coast Institute for Research, LLC

Macon, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33214190 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VGo Switch

Identifier Type: -

Identifier Source: org_study_id