Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 17, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE April 9, 2018
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Evaluate the change In HbA1c between groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Evaluate the prevalence of hypoglycemic events between groups based on 7- point glucose profiles. [ Time Frame: 12 weeks ]
  • Evaluate the incidence of hypoglycemic events between groups based on 7- point glucose profiles. [ Time Frame: 12 weeks ]
  • Evaluate the change in total daily doses (units/kg) of insulin between groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]
  • Evaluate the change in total daily doses (units/day) of insulin between groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]
  • Evaluate the difference in direct pharmacy insulin costs to insurance payor using wholesale acquisition costs between groups. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2018)
Evaluate the change in glucose patterns between groups based on 7-point glucose profiles. [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Regular Insulin vs Rapid Insulin Delivered by V-Go
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Type 2 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: VGo with Regular Human Insulin
    Intervention: Device: VGo
  • Active Comparator: VGo with Rapid Acting Insulin
    Intervention: Device: VGo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2019)
217
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
162
Actual Study Completion Date  ICMJE August 12, 2019
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495908
Other Study ID Numbers  ICMJE VGo Switch
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party East Coast Institute for Research
Study Sponsor  ICMJE East Coast Institute for Research
Collaborators  ICMJE
  • Valeritas, Inc.
  • Dallas Diabetes Research
Investigators  ICMJE Not Provided
PRS Account East Coast Institute for Research
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP