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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
A1C
Secondary study objectives
7 point glucose profile
A1c at goal
Change in glycemic control
+3 more

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:

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Who is running the clinical trial?

Valeritas, Inc.Lead Sponsor
4 Previous Clinical Trials
491 Total Patients Enrolled
Ronald Harris, MDPrincipal InvestigatorGeisinger Clinic
~9 spots leftby Sep 2025
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