Clinical Study to Compare Various Dosing and Titration Guidelines of Insulin Delivered Via V-Go ® in Patients With Type 2 Diabetes Initiating Basal Bolus Therapy in Primary Care Offices

NCT02361489 | Unknown Phase 4

• 1 other identifier: CSP-029
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• A1C

  Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).

  4 months

Secondary Outcomes (6)

• Change in glycemic control

  4 months

• Patient Treatment Satisfaction

  4 months

• Insulin Dose

  4 months

• A1c at goal

  4 months

• 7 point glucose profile

  4 months

Study Arms (2)

Titration Algorithm A

ACTIVE COMPARATOR

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).

Device: V-Go

Titration Algorithm B

ACTIVE COMPARATOR

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:

Device: V-Go

Interventions

V-Go DEVICE

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

Titration Algorithm A; Titration Algorithm B

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Valeritas, Inc.: lead

Study Sites (1)

Geisinger

Wilkes-Barre, Pennsylvania, 18702, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ronald Harris, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karrie A Hilsinger, BA

CONTACT

908-927-9920; khilsinger@valeritas.com

Scott Abbott, MS

CONTACT

610-739-9832; Sabbott@valeritas.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

US (1)