NCT03495908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2018

Completed
23 days until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 25, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

March 17, 2018

Results QC Date

December 23, 2020

Last Update Submit

February 10, 2021

Conditions

Type 2 DiabetesType 2 Diabetes Mellitus

Keywords

VGoInsulinType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline and Week 12

Secondary Outcomes (6)

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

    Baseline and Week 12

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

    Baseline and Week 12

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

    Baseline and Week 12

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

    Baseline and Week 12

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

    Baseline and Week 12

  • +1 more secondary outcomes

Other Outcomes (1)

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

    Baseline and Week 12

Study Arms (2)

VGo with Regular Human Insulin

EXPERIMENTAL

U-100 short-acting insulin, Regular, human insulin rDNA origin, including Humulin® R, Novolin® R, and ReliOn (Novolin R) delivered by V-Go

Device: VGo

VGo with Rapid Acting Insulin

ACTIVE COMPARATOR

U-100 fast-acting insulin including Humalog® (insulin lispro, rDNA origin) or NovoLog® (insulin aspart, rDNA origin), which have both been tested by Valeritas, Inc. and found to be safe for use in the V-Go or Apidra® (insulin glulisine, rDNA origin) delivered by V-Go

Device: VGo

Interventions

VGoDEVICE

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.

VGo with Rapid Acting InsulinVGo with Regular Human Insulin

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

Location

East Coast Institute for Research, LLC

Macon, Georgia, 31210, United States

Location

Related Publications (1)

  • 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.

    PMID: 33214190DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Results Point of Contact

Title
Dr Pablo F Mora
Organization
The University of Texas Southwestern Medical Center
pf_mora@yahoo.com
469-585-0000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2018

First Posted

April 12, 2018

Study Start

April 9, 2018

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

March 2, 2021

Results First Posted

January 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)