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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 463 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02735044
The ClinicalTrials.gov registry entry for NCT02735044 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 463 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 Insulin glargine,300 U/mL is the first listed.
NCT02735044 reports 0 study locations.
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.
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