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)

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

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)

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine

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 Type: Interventional
• Enrollment (Actual): 405
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Pharmaceutical form: solution for injection; Route of administration: subcutaneous; Other Names: 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; Pharmaceutical form: solution for injection; Route of administration: subcutaneous; Other Names: Lantus

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Hypoglycemic Events	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).	each study phase (crossover, re-randomization, observational) up to 40 weeks

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: October 20, 2010
• First Posted (Estimate): October 21, 2010

Study Record Updates

• Last Update Posted (Estimate): August 12, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: LANTU_L_05191; U1111-1116-3054 (Other Identifier: UTN)