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NCT02320721 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,014
- Enrollment target
NCT02320721 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,014 participants.
The verdict
NCT02320721, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,014 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning * Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event * Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day * HbA1c change
Interventions
- DRUG Background therapy
- DRUG Insulin Glargine (HOE901 - U300)
- DRUG Insulin Glargine (HOE901 - U100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,014 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02320721
The ClinicalTrials.gov registry entry for NCT02320721 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,014 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 3 interventions - of which Background therapy is the first listed.
NCT02320721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02320721 about?
NCT02320721 is a clinical study titled "Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications". Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: * Percentage of participants with at least one severe and/or confirmed (...
What is the current status of trial NCT02320721?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,014 participants. The study started on 2015-01. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02320721?
The interventions under investigation include: Background therapy (DRUG), Insulin Glargine (HOE901 - U300) (DRUG), Insulin Glargine (HOE901 - U100) (DRUG).
Who is sponsoring clinical trial NCT02320721?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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