Diabetes Type II
Conditions
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.
Interventions
DEVICEV-Go
Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.
Sponsors
Valeritas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1C | 4 months | Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Treatment Satisfaction | 4 months | • 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 | 4 months | • 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 |
| Change in glycemic control | 4 months | • 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 |
| 7 point glucose profile | 4 months | Capture and analyze seven-point glucose profile at baseline and end of study |
| Hypoglycemia | 4 months | Rates of hypoglycemic events and utilization |
| A1c at goal | 4 months | Percentage of patient achieving a A1C of ≤7% |
Countries
United States
Contacts
Primary ContactKarrie A Hilsinger, BA
Backup ContactScott Abbott, MS
Outcome results
None listed