Clinical trial NCT01226043: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Patient Overall Preference
timeFrame: At week 4 (end of crossover phase)
Secondary outcomes:
measure: Patient Preference Composite Score
timeFrame: At week 4 (end of crossover phase)
measure: Healthcare Professional's (HCP) Recommendation
timeFrame: At week 4 (end of crossover phase)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
measure: Percentage of Patients Achieving Fasting Plasma Glucose (FPG) <110 mg/dL
timeFrame: At week 10 (end of re-randomization phase)
measure: Change in Lantus Dose Injected Per Day
timeFrame: From week 4 (baseline for re-randomization phase) to week 10 (end of re-randomization phase)
measure: Percentage of Patients Achieving HbA1c Goal
timeFrame: measured at week 40 or at study discontinuation
measure: Time to First Observation of HbA1c <7%
timeFrame: From week 10 to week 40 (observational phase)
measure: Percentage of Patients Who Discontinued Investigational Product (IP) During the Crossover Phase
timeFrame: From baseline to week 4 (crossover phase)
measure: Percentage of Patients Who Discontinued Investigational Product During the Re-randomization Phase
timeFrame: From week 4 to week 10 (re-randomization phase)
measure: Percentage of Patients Who Discontinued Investigational Product During the Observational Phase
timeFrame: From week 10 to week 40 (observational phase)
Other outcomes:
measure: Number of Patients With Hypoglycemic Events
timeFrame: each study phase (crossover, re-randomization, observational) up to 40 weeks
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: