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Regular Insulin vs Rapid Insulin Delivered by V-Go

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495908
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Valeritas, Inc.
Dallas Diabetes Research
Information provided by (Responsible Party):
East Coast Institute for Research

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Type 2 Diabetes Mellitus Device: VGo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : August 12, 2019
Actual Study Completion Date : August 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VGo with Regular Human Insulin Device: 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.

Active Comparator: VGo with Rapid Acting Insulin Device: 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.




Primary Outcome Measures :
  1. Evaluate the change In HbA1c between groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Evaluate the prevalence of hypoglycemic events between groups based on 7- point glucose profiles. [ Time Frame: 12 weeks ]
  2. Evaluate the incidence of hypoglycemic events between groups based on 7- point glucose profiles. [ Time Frame: 12 weeks ]
  3. Evaluate the change in total daily doses (units/kg) of insulin between groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]
  4. Evaluate the change in total daily doses (units/day) of insulin between groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]
  5. Evaluate the difference in direct pharmacy insulin costs to insurance payor using wholesale acquisition costs between groups. [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Evaluate the change in glucose patterns between groups based on 7-point glucose profiles. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495908


Locations
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United States, Florida
East Coast Institute for Research, LLC
Jacksonville, Florida, United States, 32204
United States, Georgia
East Coast Institute for Research, LLC
Macon, Georgia, United States, 31210
Sponsors and Collaborators
East Coast Institute for Research
Valeritas, Inc.
Dallas Diabetes Research
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Responsible Party: East Coast Institute for Research
ClinicalTrials.gov Identifier: NCT03495908    
Other Study ID Numbers: VGo Switch
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by East Coast Institute for Research:
VGo
Insulin
Type 2 Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases