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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin Glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

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)

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Overall Preference

Secondary outcome:

Patient Preference Composite Score

Healthcare Professional's (HCP) Recommendation

Change in Fasting Plasma Glucose (FPG)

Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL

Change in Lantus Dose Injected Per Day

Percentage of Patients Achieving HbA1c Goal

Time to First Observation of HbA1c <7%

Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase

Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase

Percentage of Patients Who Discontinued Investigational Product During the Observational Phase

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.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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)

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States

Starting date: October 2010
Last updated: July 30, 2013