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

Diabetes Type II Clinical Trial

— TITRATE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02361489
• Other study ID #: CSP-029
• Status: Recruiting
• Phase: Phase 4
• First received: February 6, 2015
• Last updated: February 6, 2015
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2015
• Source: Valeritas, Inc.
• Contact: Karrie A Hilsinger, BA
• Phone: 908-927-9920
• Email: khilsinger[@]valeritas.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type II

Intervention

Device:
• V-Go
Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.

Locations

Country	Name	City	State
United States	Geisinger	Wilkes Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Valeritas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1C	Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).	4 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	A1c at goal	Percentage of patient achieving a A1C of =7%	4 months	No
Secondary	7 point glucose profile	Capture and analyze seven-point glucose profile at baseline and end of study	4 months	No
Secondary	Hypoglycemia	Rates of hypoglycemic events and utilization	4 months	No