Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT02735044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02735044
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 463 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 14, 2016 (Actual)
- Primary completion
- May 31, 2018 (Actual)
- Completion
- Dec 20, 2018 (Actual)
- Last update posted
- Mar 25, 2022
2016 – 2018
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400008 | Tucson | Arizona | 85724 | — |
| Investigational Site Number 8400037 | Atlanta | Georgia | 30318 | — |
| Investigational Site Number 8400032 | Indianapolis | Indiana | 46202 | — |
| Investigational Site Number 8400015 | Buffalo | New York | 14222 | — |
| Investigational Site Number 8400016 | Chapel Hill | North Carolina | 27599-7295 | — |
| Investigational Site Number 8400035 | Morehead City | North Carolina | 28557 | — |
| Investigational Site Number 8400038 | Oklahoma City | Oklahoma | 73112 | — |
| Investigational Site Number 8400030 | Philadelphia | Pennsylvania | 19104 | — |
| Investigational Site Number 8400010 | Rapid City | South Dakota | 57701 | — |
| Investigational Site Number 8400005 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8400021 | Dallas | Texas | 75235 | — |
| Investigational Site Number 8400029 | Lufkin | Texas | 75904 | — |
| Investigational Site Number 8400034 | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02735044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 25, 2022 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02735044 live on ClinicalTrials.gov.