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

NCT ID: NCT02361489

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-04-30

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.

Detailed Description

This study addresses the informational needs of Primary Care Physicians with regard to providing insulin dosing and titration information utilizing a V-Go disposable insulin delivery device. We look to compare two treatment arms of insulin dosing and titration in patients with Type 2 insulin-dependent diabetes - a fixed dose titration arm, and an arm where 50% of the insulin dose is given at the largest meal of the day. This study will provide practical information on glycemic control, dose requirements and safety in patients with Type 2 diabetes on basal insulin with or without oral anti-diabetic agents who are being primarily managed in the primary care office.

Conditions

Diabetes Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

V-Go

Intervention Type: DEVICE

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

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:

Group Type: ACTIVE_COMPARATOR

V-Go

Intervention Type: DEVICE

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

Interventions

V-Go

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeritas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Harris, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger

Wilkes-Barre, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karrie A Hilsinger, BA

Role: CONTACT

khilsinger@valeritas.com

908-927-9920 ext. 20116

Scott Abbott, MS

Role: CONTACT

Sabbott@valeritas.com

610-739-9832

Facility Contacts

Amy B Cartaya,, MSHA

Role: primary

abcartaya@geisinger.edu

570-214-9544

Natacha M Antunes, BS, MPH

Role: backup

NMANTUNES@geisinger.edu

570-214-6985

Other Identifiers

CSP-029

Identifier Type: -

Identifier Source: org_study_id