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)

Valeritas

Status and phase: Unknown; Phase 4

Conditions: Diabetes Type II

Treatments: Device: V-Go

Study type: Interventional

Funder types: Industry

Identifiers

NCT02361489

CSP-029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Titration Algorithm A

Active Comparator group

Description:

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).

Treatment:

Device: V-Go

Titration Algorithm B

Active Comparator group

Description:

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:

Treatment:

Device: V-Go