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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
405
* Pharmaceutical form: solution for injection * Route of administration: subcutaneous
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Patient Overall Preference
The patient preference was assessed in terms of the difference in scores obtained from the overall preference question 14d "Overall, what is your level of preference for each of the insulin delivery systems?" 5 points scale: from 1=Not preferred to 5= Always preferred
Time frame: At week 4 (end of crossover phase)
Patient Preference Composite Score
The patient preference composite score was the sum of the scores of the 3 following individual preference questions from the Patient preference Questionnaire: * Question 14a: How strongly do you prefer each of these insulin delivery systems to control blood sugar? * Question 14b: If using insulin for the first time, how strongly would you prefer using each of these delivery systems to overcome reluctance to use insulin? * Question 14c: How strongly would you prefer each insulin delivery system for long-term use? Each individual question scored from 1 to 5. The lowest score 1 indicated 'Not Preferred' and the highest score 5 indicated 'Always Preferred'. Therefore the total range of the composite score was 3 to 15.
Time frame: At week 4 (end of crossover phase)
Healthcare Professional's (HCP) Recommendation
The overall recommendation score was obtained from the question 20d of the Healthcare Professional Questionnaire: "Overall, how strongly would you recommend each of the insulin delivery systems for your patients?" 5 points scale: from 1= Not Recommended to 5= Recommended
Time frame: At week 4 (end of crossover phase)
Change in Fasting Plasma Glucose (FPG)
Time frame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
Time frame: At week 10 (end of re-randomization phase)
Change in Lantus Dose Injected Per Day
Time frame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving HbA1c Goal
Percentage of patients achieving HbA1c \< 7% at Week 40 (end of the observational phase)
Time frame: measured at week 40 or at study discontinuation
Time to First Observation of HbA1c <7%
Time frame: From week 10 to week 40 (observational phase)
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
Time frame: From baseline to week 4 (crossover phase)
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
Time frame: From week 4 to week 10 (re-randomization phase)
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
Time frame: From week 10 to week 40 (observational phase)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.