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NCT02227862 · ClinicalTrials.gov registry record · Phase 3
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
A Phase 3 study, sponsored by Mylan.
- Completed
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT02227862 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 558 participants.
The verdict
NCT02227862, a Phase 3 study, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 558 participants
- Enrollment target
Study Summary
To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.
Interventions
- DRUG Mylan's insulin glargine
- DRUG Lantus®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02227862
The ClinicalTrials.gov registry entry for NCT02227862 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 558 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mylan's insulin glargine is the first listed.
NCT02227862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02227862 about?
NCT02227862 is a clinical study titled "Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)". To test whether Mylan's insulin glargine once daily is non-inferior to Lantus® once daily (based on change in HbA1c from baseline to 24 weeks) when administered in combination with mealtime insulin lispro.
What is the current status of trial NCT02227862?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2014-06. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02227862?
The interventions under investigation include: Mylan's insulin glargine (DRUG), Lantus® (DRUG).
Who is sponsoring clinical trial NCT02227862?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
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