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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 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 405 participants.
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)
Interventions
- DRUG Insulin Glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01226043
The ClinicalTrials.gov registry entry for NCT01226043 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 405 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Insulin Glargine is the first listed.
NCT01226043 reports 0 study locations.
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.
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