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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titration Algorithm A | Active Comparator | 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). |
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| Titration Algorithm B | Active Comparator | 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: |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-Go | Device | Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| A1C | Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Treatment Satisfaction |
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:Patients presenting with any the following exclusion criteria will not be eligible for enrollment into the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karrie A Hilsinger, BA | Contact | 908-927-9920 | 20116 | khilsinger@valeritas.com |
| Scott Abbott, MS | Contact | 610-739-9832 | Sabbott@valeritas.com |
| Name | Affiliation | Role |
|---|---|---|
| Ronald Harris, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger | Recruiting | Wilkes-Barre | Pennsylvania | 18702 | United States |
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• 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 |
| 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 |
| A1c at goal | Percentage of patient achieving a A1C of ≤7% | 4 months |
| 7 point glucose profile | Capture and analyze seven-point glucose profile at baseline and end of study | 4 months |
| Hypoglycemia | Rates of hypoglycemic events and utilization | 4 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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