Your session is about to expire
← Back to Search
Insulin Delivery Device
Titration Algorithm A for Diabetes (TITRATE Trial)
Phase 4
Waitlist Available
Led By Ronald Harris, MD
Research Sponsored by Valeritas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 21 and ≤80 at time of study enrollment
Ability to read and understand English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
TITRATE 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.
Eligible Conditions
- Diabetes
TITRATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTITRATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
A1C
Secondary outcome measures
7 point glucose profile
A1c at goal
Change in glycemic control
+3 moreTITRATE Trial Design
2Treatment groups
Active Control
Group I: Titration Algorithm AActive Control1 Intervention
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).
Group II: Titration Algorithm BActive Control1 Intervention
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:
Find a Location
Who is running the clinical trial?
Valeritas, Inc.Lead Sponsor
4 Previous Clinical Trials
491 Total Patients Enrolled
Ronald Harris, MDPrincipal InvestigatorGeisinger Clinic
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Share this study with friends
Copy Link
Messenger