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: Completed
• Trial end date: 2012-05-01

Summary

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)

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc