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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Glargine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with a confirmed diagnosis of type 2 diabetes mellitus who were treated with any combination of 2 or 3 oral antidiabetic drugs (OADs) at a stable dose for the preceding 3 months, including but not limited to: Metformin + sulfonylurea + thiazolidinedione (Pioglitazone) Metformin + sulfonylurea Metformin + thiazolidinedione (Pioglitazone) Metformin + dipeptidyl peptidase (DPPIV) And for whom the Investigator/treating physician had decided that basal insulin was appropriate. Patients who had signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form Exclusion criteria: Patients less than 18 years or greater than 85 years of age (ie, have not reached the age of 86 at the screening visit) Patients with a confirmed diagnosis of type 1 diabetes mellitus Patients who were treated with insulin or who had been treated with insulin in the preceding 12 months with the exception of insulin treatment during hospitalization (ie, patients who received insulin while hospitalized could be included) Patients whose screening HbA1c is <7% or >10% Patients with current addiction or current alcohol / drug abuse Patients with cardiac status New York Heart Association III-IV Patients with stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or unstable angina pectoris within the 12 months prior to screening Patients with a diagnosis of dementia, severe visual or dexterity impairment Patients with any malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ Patients with concomitant disease or concomitant medication that could interfere with treatment or ability to answer questionnaires Patients who were unable to self-inject Patients who were taking or had been treated with Byetta® (exenatide) or other Glucagon-Like Peptide-1 agonists within 3 months before screening: Patients who were pregnant or breastfeeding Women of childbearing potential not protected by a highly effective contraceptive method of birth control (as defined for contraception in the Informed Consent Form and /or in a local protocol addendum) and/or who were unwilling or unable to be tested for pregnancy Patients with impaired renal function as shown by serum creatinine ≥1.5 mg/dL for males or ≥1.4 mg/dL for females at screening Patients with clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of the normal range (ULN) Patients unlikely to comply with the protocol requirements (eg, illiterate, uncooperative, unable to return for scheduled visits, unlikely to complete the study)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lantus (insulin glargine) vial & syringe<br>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<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>* Other names: Lantus;|
| Experimental: Lantus (insulin glargine) SoloSTAR pen<br>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<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At week 4 (end of crossover phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | At week 4 (end of crossover phase) | 
| 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 | Percentage of patients achieving HbA1c < 7% at Week 40 (end of the observational phase) | measured at week 40 or at study discontinuation | 
| 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) |