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NCT02803918 · ClinicalTrials.gov registry record · Phase 1
A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT02803918: Completed Phase 1 study, sponsored by Sanofi.
NCT02803918 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02803918, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM. Secondary Objectives: * To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic parameters of repeated lixisenatide doses in pediatric patients with T2DM. * To evaluate the change from baseline in fasting and post-prandial plasma glucose concentrations during a standardized meal test after 3 ascending repeated doses of lixisenatide in comparison to placebo.
Interventions
- DRUG Placebo
- DRUG Metformin
- DRUG Lixisenatide (AVE0010)
- DRUG Basal Insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 1 |
What the finished NCT02803918 record still lists
NCT02803918 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02803918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02803918 about?
NCT02803918 is a clinical study titled "A Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus (T2DM)". Primary Objective: To demonstrate safety of 14-day repeated lixisenatide doses with 3 ascending doses as compared to placebo in pediatric patients with T2DM. Secondary Objectives: * To evaluate plasma concentrations of lixisenatide after repeated doses (3 ascending doses) and pharmacokinetic para...
What is the current status of trial NCT02803918?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2017-05-17. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT02803918?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lixisenatide (AVE0010) (DRUG), Basal Insulin (DRUG).
Who is sponsoring clinical trial NCT02803918?
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 NCT02803918's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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