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)
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Valeritas, Inc.
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- A1C
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
A1C
Time Frame: 4 months
Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).
Secondary Outcomes
- 7 point glucose profile(4 months)
- Patient Treatment Satisfaction(4 months)
- A1c at goal(4 months)
- Hypoglycemia(4 months)
- Change in glycemic control(4 months)
- Insulin Dose(4 months)