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Completed

NCT Number: NCT03495908

Regular Insulin vs Rapid Insulin Delivered by V-Go

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Coast Institute for Research, LLC, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 21 years at time of study enrollment
  • Diagnosed with T2D for at least 6 months prior to screening
  • Screening visit A1C ≥ 7.0% and ≤ 12.5%
  • 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
  • Ability to read and understand English
  • Willing to complete all study related activities
  • 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
  • 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).
  • Completed a 7-point glucose profile prior to Visit 2
  • 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

  • Subject with confirmed Type 1 diabetes
  • More than 1 episode of severe hypoglycemia (defined as requiring third party assistance) within 3 months of study entry
  • History of hypoglycemia unawareness
  • Require supplemental insulin in addition to V-Go therapy
  • 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.
  • Woman who are lactating.
  • 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
  • A recipient of a solid organ transplant
  • Current use of U-100 RHI in V-Go within 90 days of screening
  • Current use of U-500 RHI in V-Go within 90 days of screening
  • Currently on dialysis
  • Medical or other problems which in the opinion of the investigator will render study participation unsafe.

Treatment and study plan

VGo

Device

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 outcomes

  1. Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Non-inferiority Hypothesis.

    Time frame: Baseline and Week 12

    Per protocol population for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference.

Secondary outcomes

  1. Evaluate the Prevalence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.

    Time frame: Baseline and Week 12

    Number of participants reporting 7-Point Hypoglycemia based on 7-point glucose profiles. Intent-to-treat (ITT) Population N=136

  2. Evaluate the Incidence of Hypoglycemic Events Between Groups Based on 7- Point Glucose Profiles.

    Time frame: Baseline and Week 12

    Level 1 (≤70 mg/dL or (<3.9 mmol/L)) and level 2 hypoglycemia (<54 mg/dL (<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.

  3. Evaluate the Change in Total Daily Doses (Units/kg) of Insulin Between Groups After 12 Weeks of Treatment.

    Time frame: Baseline and Week 12

    Between group differences in Insulin TDD U/day. Intent-to-treat Population, n=136

  4. Evaluate the Change in Total Daily Doses (TDD), Units/Day of Insulin Between Groups After 12 Weeks of Treatment.

    Time frame: Baseline and Week 12

    RHI versus RAI, comparing the change in total daily dose (TDD), units/day of insulin between groups. Intent-to-treat Population N=136

  5. Evaluate the Difference in Direct Pharmacy Insulin Costs to Insurance Payor Using Wholesale Acquisition Costs Between Groups.

    Time frame: Baseline and Week 12

    Cost Analysis for direct diabetes-related pharmacy insulin costs. All insulin costs are normalized to 30-days and based on the prescribed TDD at V2 (Baseline) and at study end (EOS) and multiplying the insulin dose in units by the average unit cost of the prescribed insulin

  6. Evaluate the Change In HbA1c Between Groups After 12 Weeks of Treatment. Intent-to-treat Population Secondary Outcome, Non-inferiority Hypothesis.

    Time frame: Baseline and Week 12

    Intent-to-treat population secondary outcome for assessment of non-inferiority of RHI. Week 12 change from baseline in HbA1c comparison of RHI versus RAI estimated treatment difference.

Other outcomes

  1. Evaluate the Change in Glucose Patterns Between Groups Based on 7-point Glucose Profiles.

    Time frame: Baseline and Week 12

    Evaluate the change between baseline and week 12 in glucose patterns between groups based on 7-point glucose profiles.

Sponsors and collaborators

Lead sponsor

East Coast Institute for Research

Network

Collaborators

  • Dallas Diabetes Research
  • Valeritas, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2018
Registry last updated
Mar 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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