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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)

Primary Purpose

Diabetes Type II

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
V-Go
Sponsored by
Valeritas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type II

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GeisingerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Titration Algorithm A

Titration Algorithm B

Arm 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).

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:

Outcomes

Primary Outcome Measures

A1C
Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).

Secondary Outcome Measures

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
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
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
A1c at goal
Percentage of patient achieving a A1C of ≤7%
7 point glucose profile
Capture and analyze seven-point glucose profile at baseline and end of study
Hypoglycemia
Rates of hypoglycemic events and utilization

Full Information

First Posted
February 6, 2015
Last Updated
February 6, 2015
Sponsor
Valeritas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02361489
Brief 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
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valeritas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Titration Algorithm A
Arm Type
Active Comparator
Arm 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).
Arm Title
Titration Algorithm B
Arm Type
Active Comparator
Arm 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:
Intervention Type
Device
Intervention Name(s)
V-Go
Intervention Description
Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.
Primary Outcome Measure Information:
Title
A1C
Description
Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in glycemic control
Description
• 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
Time Frame
4 months
Title
Patient Treatment Satisfaction
Description
• 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
Time Frame
4 months
Title
Insulin Dose
Description
• 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
Time Frame
4 months
Title
A1c at goal
Description
Percentage of patient achieving a A1C of ≤7%
Time Frame
4 months
Title
7 point glucose profile
Description
Capture and analyze seven-point glucose profile at baseline and end of study
Time Frame
4 months
Title
Hypoglycemia
Description
Rates of hypoglycemic events and utilization
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karrie A Hilsinger, BA
Phone
908-927-9920
Ext
20116
Email
khilsinger@valeritas.com
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Abbott, MS
Phone
610-739-9832
Email
Sabbott@valeritas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Harris, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger
City
Wilkes Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy B Cartaya,, MSHA
Phone
570-214-9544
Email
abcartaya@geisinger.edu
First Name & Middle Initial & Last Name & Degree
Natacha M Antunes, BS, MPH
Phone
570-214-6985
Email
NMANTUNES@geisinger.edu

12. IPD Sharing Statement

Learn more about this trial

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

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