Clinical trial NCT03495908: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Type 2 Diabetes Mellitus
Keywords: VGo
Insulin
Type 2 Diabetes
Lead sponsor: East Coast Institute for Research
Sponsor class: NETWORK
Collaborators: name: Valeritas, Inc.
name: Dallas Diabetes Research
First posted: 2018-04-12
Enrollment: 136
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
timeFrame: Baseline and Week 12
measure: Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.
timeFrame: Baseline and Week 12
measure: Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment.
timeFrame: Baseline and Week 12
measure: Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment.
timeFrame: Baseline and Week 12
measure: Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups.
timeFrame: Baseline and Week 12
measure: Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis.
timeFrame: Baseline and Week 12
Other outcomes:
measure: Evaluate the Change in Glucose Patterns Between Groups Based on 7-point Glucose Profiles.
timeFrame: Baseline and Week 12
Locations:
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Macon
country: United States
facility: East Coast Institute for Research, LLC
state: Georgia
Study officials:
References:
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.