Recruiting

Insulin

Sponsor:

Valeritas, Inc.

Code:

NCT02361489

Conditions

Diabetes Type II

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

V-Go

Study Details

Brief summary:

The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or basal insulin with oral agents can be efficiently and safely started with meal time insulin using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go) using one of two dose titration algorithms to achieve improved A1C at 4 months.

Conditions

Diabetes Type II

Study ID

NCT02361489

Start date

Feb, 2015

Status verified date

Feb, 2015

Completion date

Apr, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • Age ≥ 21 and ≤80 at time of study enrollment
  • Ability to read and understand English
  • BMI ≥ 25 kg/m2
  • Weight less than or equal to 300 pounds.
  • A1C ≥8 but ≤12% (most recent value within 4 weeks of baseline visit)
  • Currently using any basal insulin therapy (NPH, Levemir, Lantus) with total daily dose of 30 to 120 units, and where basal dose is greater than the patient's BMI #
  • Willing to attend their physician's office for follow-up visits
  • Willing and able to understand and sign a written informed consent form (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 at least 3 glucose measurements per time period (pre-breakfast, lunch, dinner and bed) per week.
  • Willing to opt-in into Valeritas Customer Care so that they can receive device support and reminders throughout the study
  • Most recent primary care office visit at one of the participating sites.

Exclusion Criteria:Patients presenting with any the following exclusion criteria will not be eligible for enrollment into the study:

  • Patient with confirmed Type 1 diabetes and/or patients with a weight greater than 300 lbs.
  • Diagnosis of an Autoimmune disease affecting metabolism
  • Currently using GLP-1 medications
  • Current (within the last 6 months) or planned use of insulin pump for diabetes management or the use of U500 insulin.
  • Ongoing participation in any clinical study
  • Pregnant, lactating or intending to become pregnant
  • Current chronic systemic steroid use
  • Prior V-Go use

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Titration Algorithm A

All patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm A will use a fixed starting dose of either 2 clicks per meal (if on the V-Go 20) or 3 clicks per meal (if on the V-Go 30).

active comparator: Titration Algorithm B

All patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm B will have 50% of their initial bolus dose given at the largest meal with less bolus insulin at the other meals as noted below:

Interventions

V-Go

Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.

Primary outcome measure

  • A1C [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Karrie A Hilsinger, BA

908-927-9920khilsinger@valeritas.com

Scott Abbott, MS

610-739-9832Sabbott@valeritas.com

Locations

Geisinger

Recruiting

Wilkes Barre, Pennsylvania, United States, 18702

Contacts

Amy B Cartaya,, MSHA

570-214-9544abcartaya@geisinger.edu

Natacha M Antunes, BS, MPH

570-214-6985NMANTUNES@geisinger.edu

More Information

Sponsor

Valeritas, Inc.

Last update posted

Feb 11, 2015

Last verified

Feb, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Valeritas, Inc. on 2015-02-11.