Regular Insulin vs Rapid Insulin Delivered by V-Go



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:2/9/2019
Start Date:April 9, 2018
End Date:December 31, 2019

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
2
sites
11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Phone: 904-384-2379
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Macon, Georgia 31210
Phone: 478-746-8626
?
mi
from
Macon, GA
Click here to add this to my saved trials