NCT02361489

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Valeritas, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Type II

Interventions

Type	Name	Description
DEVICE	V-Go	Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2015-02-11
• Last updated: 2015-02-11

Locations

1 site across 1 country: United States