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Type 2 Diabetes MellitusPhase 1NCT03211195

Sotagliflozin Bioequivalence Study

A Phase 1 study testing Sotagliflozin (SAR439954) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin (SAR439954)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
29 Jun 2017to 22 Aug 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male and female subjects 18-55 years old inclusive, male or female.
  • Certified as healthy by comprehensive clinical assessment (detailed medical history and complete physical examination).
  • Body weight between 50.0 and 100.0 kg, inclusive if male, and between 40.0 and 90.0 kg, inclusive if female, Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive.
  • Normal vital signs, ECG and laboratory parameters.
  • Female subjects must use a double contraception method including a highly effective method of contraception except if she has undergone sterilization at least 3 months earlier or is post-menopausal. Hormonal contraception is permitted in this study.
  • Having given written informed consent prior to undertaking of study procedure.
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  • Covered by a health insurance system where applicable, and/or in compliance with the recommendation of the national laws in force relating to biomedical research.
  • Not under any administrative or legal supervision.
  • Male subjects, whose partners are of childbearing potential (including lactating women) must accept to use, during sexual intercourse, a double contraception method from the inclusion up to 3 months after the last dosing.
  • Male subjects, who partners are pregnant, must use during sexual intercourse a condom from inclusion to three months after the last dosing.
  • Male subject has agreed not to donate sperm from the time of inclusion up to 3 months after the last dosing.

Who cannot join

  • Any history or presence of clinically relevant disease at screening which could interfere with the objectives of the study or the safety fo the subject's participation.
  • History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate [GFR]<90 mg/min as calculated using the Cockcroft-Gault equation) at screening.
  • Frequent headaches and/or migraines, recurrent nausea and/or vomiting.
  • Blood donation of a pint or more within 2 months before inclusion.
  • Symptomatic, postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure of 20 mmHg or more within 3 minutes when changing from supine to standing position.
  • Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
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  • Any history of presence of deep vein thrombosis or pulmonary embolism or a recurrent or frequent history of deep vein thrombosis in first degree relatives (parents, siblings, or children).
  • Any presence or history of urinary tract infection or genital mycotic infection in the last 4 weeks before screening.
  • History or presence of drug or alcohol abuse.
  • Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
  • Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
  • If female, pregnancy (defined as positive beta-HCG) blood test if applicable) breast-feeding.
  • Any medication (including St John's Wort) within 14 days before inclusion or within 5 time the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion or within 5 terminal elimination half-life of the biologic.
  • Any subject in the exclusion period of a previous study according to applicable regulations.
  • Any subject who cannot be contracted in the case of an emergency.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Investigational Site Number 840001

    Miami, Florida, 33014

Other trials in United States

About this study

Official title: Bioequivalence Study Comparing Sotagliflozin Tablet Commercial Formulation (Test) and Sotagliflozin Tablet Development Formulation (Reference) in Healthy Male and Female Subjects Under Fasted Conditions

Primary Objective:

To determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects.

Read more

Secondary Objectives:

  • To evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-O-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions.
  • To evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.
Read the detailed description

The study duration per subject will be 36-99 days and will consist of a screening period of 2 to 21 days, a study period of 7 days for each of four periods, and a washout of 8-21 days between each dose administration, and a final follow up visit 10-15 days after final dose administration.

Being tested
Sotagliflozin (SAR439954)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sotagliflozin (SAR439954)Drug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT03211195
Study groupRoleWhat they receive
Sotagliflozin - CommericalExperimentalHealthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Commercial formulation) by mouth under fasted conditions
Receives: Drug: Sotagliflozin (SAR439954)
Sotagliflozin -DevelopmentActive comparatorHealthy volunteers will be administered a single dose Sotagliflozin (SAR439954) tablet (Development formulation) by mouth under fasted conditions - Type: Active Comparator
Receives: Drug: Sotagliflozin (SAR439954)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of PK (pharmacokinetic) parameter: Cmax

    Sotagliflozin: Maximum plasma concentration (Cmax)

    Measured: From 0 to 120 hours after SAR439954 intake

  2. Assessment of PK parameter: AUClast

    Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)

    Measured: From 0 to 120 hours after SAR439954 intake

  3. Assessment of PK parameter: AUC

    Sotagliflozin: Area under the concentration-time curve from 0 to infinity

    Measured: From 0 to 120 hours after SAR439954 intake

Secondary outcomes (10)

  1. Assessment of PK parameter: Tmax

    Sotagliflozin: Time to reach maximum plasma concentration (Tmax)

    Measured: From 0 to 120 hours after SAR439954 intake

  2. Assessment of PK parameter: t1/2

    Sotagliflozin: Terminal elimination half life (T1/2)

    Measured: From 0 to 120 hours after SAR439954 intake

  3. Assessment of PK parameter: Vz/F

    Sotagliflozin: Apparent volume of distribution during terminal phase after non-intravenous administration Vz/F

    Measured: From 0 to 120 hours after SAR439954 intake

  4. Assessment of PK parameter: CL/F

    Sotagliflozin: Apparent total body clearance of a drug from the plasma (CL/F)

    Measured: From 0 to 120 hours after SAR439954 intake

  5. Assessment of PK parameter: Cmax

    Sotagliflozin 3-O-glucuronide: Maximum plasma concentration (Cmax)

    Measured: From 0 to 120 hours after SAR439954 intake

  6. Assessment of PK parameter: AUC

    Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to infinity

    Measured: From 0 to 120 hours after SAR439954 intake

  7. Assessment of PK parameter: AUClast

    Sotagliflozin 3-O-glucuronide: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)

    Measured: From 0 to 120 hours after SAR439954 intake

  8. Assessment of PK parameter: Tmax

    Sotagliflozin 3-O-glucuronide: Time to reach maximum plasma concentration (Cmax)

    Measured: From 0 to 120 hours after SAR439954 intake

  9. Assessment of PK parameter: t1/2

    Sotagliflozin 3-O-glucuronide: Terminal elimination half life (T1/2)

    Measured: From 0 to 120 hours after SAR439954 intake

  10. Treatment emergent adverse events (TEAE)

    Number treatment emergent adverse events

    Measured: From 0 to 144 hours after SAR439954 intake

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2017
  2. Study start29 Jun 2017
  3. Primary completion22 Aug 2017
  4. Study completion22 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03211195
Sponsor's protocol ID
BEQ15271
Other IDs
U1111-1197-7610
Status last verified
Apr 2022
First submitted
6 Jul 2017
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sotagliflozin (SAR439954) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of PK (pharmacokinetic) parameter: Cmax (time frame: From 0 to 120 hours after SAR439954 intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03211195.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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