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NCT02625636 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients
A Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02625636 is a Phase 1 study of Type 1 Diabetes Mellitus that has completed, run by Sanofi. The registered enrollment target is 20 participants, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02625636, a Phase 1 study of Type 1 Diabetes Mellitus, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients. Secondary Objective: To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.
Conditions Studied
Interventions
- DRUG placebo
- DRUG SAR438544
- DRUG r-glucagon
Study Locations (1)
California
- Investigational Site Number 840001 - Chula Vista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02625636
The ClinicalTrials.gov registry entry for NCT02625636 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (86% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT02625636 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02625636 about?
NCT02625636 is a clinical study titled "A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients". Primary Objective: To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients. Secondary Objective: To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR...
What is the current status of trial NCT02625636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2015-12. Estimated completion is 2016-02.
What conditions does trial NCT02625636 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT02625636?
The interventions under investigation include: placebo (DRUG), SAR438544 (DRUG), r-glucagon (DRUG).
Who is sponsoring clinical trial NCT02625636?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02625636 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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