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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: Completed Phase 3 study, sponsored by Sanofi.
NCT02320721 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,014 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
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 |
What the finished NCT02320721 record still lists
NCT02320721 is an interventional study that assigns participants to a tested intervention. Its 1,014 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 3 interventions - of which Background therapy is the first listed.
NCT02320721 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02320721's enrollment target sits among peer trials
1,014 294th of 2000 higher than 1,707 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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