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 |
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.
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