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 (Pen Preference)
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)
To compare Lantus SoloSTAR pen versus Lantus vial and syringe with regard to the following parameters:
- Healthcare professional's (HCP) recommendation for Lantus SoloSTAR pen versus Lantus vial and syringe
- 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
- 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
- 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)
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Patient Overall Preference [ Time Frame: At week 4 (end of crossover phase) ]
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
- Patient Preference Composite Score [ Time Frame: At week 4 (end of crossover phase) ]
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.
- Healthcare Professional's (HCP) Recommendation [ Time Frame: At week 4 (end of crossover phase) ]
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
- 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 [ Time Frame: measured at week 40 or at study discontinuation ]Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase)
- 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) ]
- Number of Patients With Hypoglycemic Events [ Time Frame: each study phase (crossover, re-randomization, observational) up to 40 weeks ]The hypoglycemic event was to be recorded on the electronic case report form hypoglycemia page and had to fit in one of the following categories: Mild-to-moderate hypoglycemia (36 mg/dL ≤ Self Monitored Blood Glucose (SMBG) <70mg/dL), Severe hypoglycemia (assistance of another person is required, and either a recorded SMBG <36 mg/dL, or treatment with oral carbohydrates, intravenous glucose or glucagon with prompt response) or Hypoglycemia symptoms with or without SMBG values with a documented SMBG >70 mg/dL, or no recorded SMBG value. Only hypoglycemia events associated with coma, loss of consciousness or seizure were considered serious adverse event (SAEs).
|Study Start Date:||October 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Lantus (insulin glargine) vial & syringe
10 mL vial, 1000 U per vial for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.
Drug: Insulin Glargine
Other Name: Lantus
Experimental: Lantus (insulin glargine) SoloSTAR pen
3 mL SoloSTAR pre-filled disposable insulin delivery device (pen), 300 U per device for subcutaneous administration once a day. Starting dose will be 0.2 Unit per kilogram of body weight.
Drug: Insulin Glargine
Other Name: Lantus
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226043
|United States, New Jersey|
|Sanofi-Aventis Administrative Office|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Clinical Sciences & Operations||Sanofi|