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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 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 23 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02803918
The ClinicalTrials.gov registry entry for NCT02803918 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 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 4 interventions - of which Placebo is the first listed.
NCT02803918 reports 0 study locations.
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.
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