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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: Completed Phase 1 study of Type 1 Diabetes Mellitus, sponsored by Sanofi.

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 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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

Type 1 Diabetes Mellitus

Interventions

  • DRUG placebo
  • DRUG SAR438544
  • DRUG r-glucagon

Study Locations (1)

California

  • Investigational Site Number 840001 - Chula Vista

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2015-12
Est. Completion 2016-02
Phase Phase 1
Sanofi

713 total trials

What the finished NCT02625636 record still lists

NCT02625636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (88% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Type 1 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02625636's enrollment target sits among peer trials

20 87th of 112 higher than 21 of 112 other Type 1 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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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Related registry views

Source: ClinicalTrials.gov NCT02625636, the US trial registry maintained by the National Library of Medicine. NCT02625636 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.