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

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
Diabetes Type II

Intervention / Treatment
-----------------
* Device: V-Go


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Titration Algorithm A<br>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<br>* Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.<br>|
| Active Comparator: Titration Algorithm B<br>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<br>* Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.<br>|

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 |