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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

NCT01226043 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2013-08-12

Study results available
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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)

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226043 on ClinicalTrials.gov