Diabetes Mellitus, Type 2 Clinical Trial
Official title:
An Open Label Randomized Multicenter Study to Assess Patient Preference for and Evaluate Clinical Benefit of Insulin Glargine (Lantus®) SoloSTAR® Pen Versus Conventional Vial/Syringe Method of Insulin Glargine (Lantus®) Injection Therapy in Patients With Type 2 Diabetes Mellitus
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 week 10
Observational phase:
- Percentage of patients achieving glycosylated hemoglobin (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 consisted 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 was up to 41 weeks with a total treatment duration
of up to 40 weeks of Lantus exposure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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