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

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.

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