Regular Insulin vs Rapid Insulin Delivered by V-Go

East Coast Institute for Research

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Type 2 Diabetes

Treatments: Device: VGo

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT03495908

VGo Switch

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

VGo with Regular Human Insulin

Experimental group

Description:

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

Treatment:

Device: VGo

VGo with Rapid Acting Insulin

Active Comparator group

Description:

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

Treatment:

Device: VGo