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NCT01572649 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01572649 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 24 participants.
The verdict
NCT01572649, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Primary Objective: \- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls Secondary Objectives: \- To evaluate in both paediatric and adult populations: * the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses * the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast * safety and tolerability.
Interventions
- DRUG Placebo
- DRUG Lixisenatide (AVE0010)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572649
The ClinicalTrials.gov registry entry for NCT01572649 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 2 interventions - of which Placebo is the first listed.
NCT01572649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01572649 about?
NCT01572649 is a clinical study titled "Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes". Primary Objective: \- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls Secondary Objectives: \- To evaluate in both...
What is the current status of trial NCT01572649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-05. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01572649?
The interventions under investigation include: Placebo (DRUG), Lixisenatide (AVE0010) (DRUG).
Who is sponsoring clinical trial NCT01572649?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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