Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01226043 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 405
- Enrollment target
NCT01226043: Completed Phase 4 study, sponsored by Sanofi.
NCT01226043 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 405 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01226043, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 405 participants
- Enrollment target
Study 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)
Primary Outcome
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
Interventions
- DRUG Insulin Glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
What the finished NCT01226043 record still lists
NCT01226043 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 1 intervention - of which Insulin Glargine is the first listed.
NCT01226043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01226043 about?
NCT01226043 is a clinical study titled "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". 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 fol...
What is the current status of trial NCT01226043?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 405 participants. The study started on 2010-10. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01226043?
The interventions under investigation include: Insulin Glargine (DRUG).
Who is sponsoring clinical trial NCT01226043?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01226043's enrollment target sits among peer trials
405 209th of 2000 higher than 1,792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05576350 · 405 participants · NA
TRAC-ER Intervention to Reduce Risky Alcohol Use and HIV Risk
- NCT07066657 · 405 participants · Phase 1
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
- NCT06223360 · 406 participants · Phase 2
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)
- NCT06411769 · 406 participants · NA
Evidence-based Intervention to Improve Walking Engagement in El Paso, Texas
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia