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

NCT ID: NCT01226043

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-05-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous

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.

Group Type: EXPERIMENTAL

Insulin Glargine

Intervention Type: DRUG

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous

Interventions

Insulin Glargine

• Pharmaceutical form: solution for injection
• Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Lantus

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

U1111-1116-3054

Identifier Type: OTHER

Identifier Source: secondary_id

LANTU_L_05191

Identifier Type: -

Identifier Source: org_study_id