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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine

• Registration Number: NCT01226043
• Lead Sponsor: Sanofi

Brief 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)

Detailed Description

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2013-05-03
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-29
• Results First Posted: 2013-07-30
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lantus (insulin glargine) vial & syringe	Insulin Glargine	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.
Lantus (insulin glargine) SoloSTAR pen	Insulin Glargine	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.

Primary Outcome Measures

Name	Time	Method
Patient Overall Preference	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

Secondary Outcome Measures

Name	Time	Method
Patient Preference Composite Score	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	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)	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	At week 10 (end of re-randomization phase)
Change in Lantus Dose Injected Per Day	From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
Percentage of Patients Achieving HbA1c Goal	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%	From week 10 to week 40 (observational phase)
Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase	From baseline to week 4 (crossover phase)
Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase	From week 4 to week 10 (re-randomization phase)
Percentage of Patients Who Discontinued Investigational Product During the Observational Phase	From week 10 to week 40 (observational phase)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States