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 (TITRATE)

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 (Short Title: TITRATE)

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Type II
• Intervention / Treatment: Device: V-Go

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karrie A Hilsinger, BA; Phone Number: 20116 908-927-9920; Email: khilsinger@valeritas.com
• Study Contact Backup: Name: Scott Abbott, MS; Phone Number: 610-739-9832; Email: Sabbott@valeritas.com

Study Locations

• United States
  • Pennsylvania
    • Wilkes Barre, Pennsylvania, United States, 18702
      • Recruiting
      • Geisinger
      • Contact: Amy B Cartaya,, MSHA; Phone Number: 570-214-9544; Email: abcartaya@geisinger.edu
      • Contact: Natacha M Antunes, BS, MPH; Phone Number: 570-214-6985; Email: NMANTUNES@geisinger.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Device: V-Go; Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.
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:	Device: V-Go; Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C	Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycemic control	• Difference in the change from baseline (randomization) to end of study visit at 4 months on glycemic control (as measured by A1C level) between the two treatment groups in a pragmatic clinical practice setting	4 months
Patient Treatment Satisfaction	• Between-group and within-group differences (baseline to end of study visit at 4 months) in patient treatment satisfaction in adult Type 2 patient with diabetes in a real world setting	4 months
Insulin Dose	• Total daily dose of insulin from baseline to end of study and to evaluate the between-group and within-group differences between the two dosing and titration arms	4 months
A1c at goal	Percentage of patient achieving a A1C of ≤7%	4 months
7 point glucose profile	Capture and analyze seven-point glucose profile at baseline and end of study	4 months
Hypoglycemia	Rates of hypoglycemic events and utilization	4 months

Collaborators and Investigators

• Sponsor: Valeritas, Inc.
• Investigators: Principal Investigator: Ronald Harris, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ANTICIPATED): February 1, 2016
• Study Completion (ANTICIPATED): April 1, 2016

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (ESTIMATE): February 11, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 11, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CSP-029