Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus



Status:Archived
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010
End Date:May 2012

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An Open Label Randomized Crossover Study to Assess Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial/Syringe Method of Insulin Glargine (Lantus) Injection Therapy in Patients With T2DM


Primary Objective:

To assess patient preference for Lantus SoloSTAR pen versus Lantus vial and syringe at the
end of Crossover Phase (Week 4) in patients with type 2 diabetes mellitus (T2DM)

Secondary Objectives:

To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following
parameters:

Randomization/Crossover phase:

>Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial
and syringe

Re-randomization phase:

- change in Fasting plasma glucose (FPG) from week 4 to week 10

- Percentage of patients achieving FPG<110 mg/dL at week 10

- change in Lantus dose injected per day (U) from week 4 to wekk 10

Observational phase:

- percentage of patients achieving HbA1c goal (<7%) at week 40

- time to first observation of HbA1c<7% during the observational phase

- percentage of patients who discontinue investigational product (IP) during the
observational phase due to dissatisfaction with their current device

All phases:

- percentage of patients who discontinue IP during each phase of the study

- safety assessment such as occurrence of hypoglycemic events (HE) and adverse events
(AE)


This study consists of a 1 week Screening Phase, a 4-week Randomization/Crossover Phase, a
6-week Re-randomization Phase, followed by a 30 week Observational Phase.

The total duration of study participation is up to 41 weeks with a total treatment duration
of up to 40 weeks of Lantus exposure.


We found this trial at
1
site
Bridgewater, New Jersey
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mi
from
Bridgewater, NJ
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