Diabetes Type II Clinical Trial
— TITRATEOfficial 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)
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Geisinger | Wilkes Barre | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Valeritas, Inc. |
United States,
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 |
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