Clinical trial NCT02361489: 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
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Type II
Lead sponsor: Valeritas, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-11
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: A1C
timeFrame: 4 months
Secondary outcomes:
measure: Change in glycemic control
timeFrame: 4 months
measure: Patient Treatment Satisfaction
timeFrame: 4 months
measure: Insulin Dose
timeFrame: 4 months
measure: A1c at goal
timeFrame: 4 months
measure: 7 point glucose profile
timeFrame: 4 months
measure: Hypoglycemia
timeFrame: 4 months
Other outcomes:
Locations:
city: Wilkes Barre
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Ronald Harris, MD
role: PRINCIPAL_INVESTIGATOR
References: