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NCT02735044 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 463
- Enrollment target
NCT02735044: Completed Phase 3 study, sponsored by Sanofi.
NCT02735044 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 463 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02735044, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 463 participants
- Enrollment target
Study Summary
Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: * Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). * To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
Primary Outcome
Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.
Interventions
- DRUG Insulin glargine,300 U/mL
- DRUG Insulin glargine (100 units /mL)
- DRUG Background therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 463 participants |
| Start Date | 2016-04-14 |
| Est. Completion | 2018-12-20 |
| Phase | Phase 3 |
What the finished NCT02735044 record still lists
NCT02735044 is an interventional study that assigns participants to a tested intervention. The registered 463 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Insulin glargine,300 U/mL is the first listed.
NCT02735044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02735044 about?
NCT02735044 is a clinical study titled "Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus". Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in term...
What is the current status of trial NCT02735044?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 463 participants. The study started on 2016-04-14. Estimated completion is 2018-12-20.
What interventions are being tested in trial NCT02735044?
The interventions under investigation include: Insulin glargine,300 U/mL (DRUG), Insulin glargine (100 units /mL) (DRUG), Background therapy (DRUG).
Who is sponsoring clinical trial NCT02735044?
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 NCT02735044's enrollment target sits among peer trials
463 821st of 2000 higher than 1,180 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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