Type 2 Diabetes MellitusPhase 1NCT03776227
A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
A Phase 1 study testing sotagliflozin (SAR439954) in people with Type 2 Diabetes Mellitus and Healthy Subjects, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective: To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects Secondary Objectives: To evaluate the single-dose pharmacokinetics of sotagliflozin following… 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, Healthy Subjects
- 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
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 22 Apr 2019
- 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 or female subjects, between 18 and 55 years of age, inclusive.
- 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 between 18.0 and 30.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs after 10 minutes resting in supine position and after 3 minutes in standing position:
- 95 mmHg < systolic blood pressure (SBP) <140 mmHg
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- 45 mmHg < diastolic blood pressure (DBP) <90 mmHg
- 40 bpm < heart rate (HR) <100 bpm
- Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms<PR<220 ms, QRS<120 ms, QTc≤430 ms if male, ≤450 ms if female and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
- Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm.
- Female subject must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of 2 of the following 3 contraceptive options: (1) intrauterine device; (2) hormonal contraception; (3) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicule-stimulating hormone (FSH) level >30 UI/L. Hormonal contraception is acceptable in this study (contraceptive guidance will be described in the study protocol).
- Having given written informed consent prior to undertaking any study-related procedure.
- Not under any administrative or legal supervision.
- Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (intra-uterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing. Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 3 months after the last dosing.
- Male subject has agreed not to donate sperm from the inclusion up to 3 months after the last dosing.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal (especially pancreatitis), hepatic (especially biliary disease, including cholecystectomy), renal, metabolic, hematological, neurological, musculoskeletal, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation (7) at screening.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- 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 ≥20 mmHg 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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- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Smoking more than 5 cigarettes or equivalent per day and/or 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 human chorionic gonadotropin (β-HCG blood test), breast-feeding.
- Any medication (over-the counter or prescription medications, including St John's Wort), or any herbal supplements or supra-therapeutic vitamins within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the substance; any vaccination within the last 28 days, and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- Any subject in the exclusion period of a previous study according to applicable regulations.
- Any subject who cannot be contacted in case of emergency.
- Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti HIV1 and anti HIV2 Ab).
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol test.
- Any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion.
- Any history or presence of deep leg 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.
- 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 8400001
Miami, Florida, 33014
About this study
Primary Objective:
To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects
Secondary Objectives:
- To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions
- To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects
Read the detailed description
Study duration per participant is approximately 103 days including a screening period up to 21 days before first dose, 4 periods of dosing and pharmacokinetic (PK) sampling each lasting 7 days, a washout period of 8-21 days between dosing, and an end of study visit 10-15 days after the last dose.
- Conditions
- Type 2 Diabetes Mellitus, Healthy Subjects
- 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 group | Role | What they receive |
|---|---|---|
| Sotagliflozin Test | Experimental | One tablet of sotagliflozin administered orally under fasting conditions Receives: Drug: sotagliflozin (SAR439954) |
| Sotagliflozin Reference | Active comparator | Two tablets of sotagliflozin administered orally under fasting conditions Receives: Drug: sotagliflozin (SAR439954) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration observed
Measured: Day 1 of each period
AUC 0-72h (area under the curve)
Truncated AUC 0-72h
Measured: Day 1 to Day 3 of each period
Secondary outcomes (8)
Time to reach Cmax (tmax)
Time to reach Cmax
Measured: Day 1 of each period
Terminal half-life (t1/2z)
Terminal half-life associated with the terminal slope (λz)
Measured: Day 1 to Day 7 of each period
Area under the plasma concentration versus time curve (AUClast)
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Measured: Day 1 to Day 7 of each period
Adverse events
Number of participants with adverse events
Measured: Day 1 to Day 7 of each period
Electrocardiograms (ECGs)
Number of patients with clinically significant changes in electrocardiograms (ECGs)
Measured: Day 1 to Day 7 of each period
Vital signs
Number of patients with clinically significant changes in vital signs
Measured: Day 1 to Day 7 of each period
Clinical laboratory tests
Number of patients with clinically significant changes in clinical laboratory tests
Measured: Day 1 to Day 7 of each period
Area under the curve (AUC)
Area under the plasma concentration versus time curve extrapolated to infinity
Measured: Day 1 to Day 7 of each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start25 Jan 2019
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776227
- Sponsor's protocol ID
- BEQ14993
- Other IDs
- U1111-1205-3319
- Status last verified
- Apr 2022
- First submitted
- 12 Dec 2018
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT03776227
- Acronym / sponsor ID
- BEQ14993
- Conditions
- Type 2 Diabetes Mellitus, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test) compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male and female subjects
Secondary Objectives:
- To evaluate the single-dose pharmacokinetics of sotagliflozin following administration of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) in healthy male and female subjects under fasting conditions
- To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference) administered under fasted conditions in healthy male and female subjects
Detailed description
Study duration per participant is approximately 103 days including a screening period up to 21 days before first dose, 4 periods of dosing and pharmacokinetic (PK) sampling each lasting 7 days, a washout period of 8-21 days between dosing, and an end of study visit 10-15 days after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin Test | Experimental | Drug: sotagliflozin (SAR439954)One tablet of sotagliflozin administered orally under fasting conditions |
| Sotagliflozin Reference | Active comparator | Drug: sotagliflozin (SAR439954)Two tablets of sotagliflozin administered orally under fasting conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy male or female subjects, between 18 and 55 years of age, inclusive.
- 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 between 18.0 and 30.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Normal vital signs after 10 minutes resting in supine position and after 3 minutes in standing position:
Key exclusion criteria (22 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal (especially pancreatitis), hepatic (especially biliary disease, including cholecystectomy), renal, metabolic, hematological, neurological, musculoskeletal, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation (7) at screening.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- 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 ≥20 mmHg within 3 minutes when changing from supine to standing position.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sotagliflozin (SAR439954)Pharmaceutical form: tablet Route of administration: oral | Drug | Sotagliflozin Reference, Sotagliflozin Test |
Primary outcome
Cmax
Time frame: Day 1 of each period
Maximum plasma concentration observed
AUC 0-72h (area under the curve)
Time frame: Day 1 to Day 3 of each period
Truncated AUC 0-72h
8 secondary outcomes
Time to reach Cmax (tmax)
Time frame: Day 1 of each period
Terminal half-life (t1/2z)
Time frame: Day 1 to Day 7 of each period
Area under the plasma concentration versus time curve (AUClast)
Time frame: Day 1 to Day 7 of each period
Adverse events
Time frame: Day 1 to Day 7 of each period
Electrocardiograms (ECGs)
Time frame: Day 1 to Day 7 of each period
Vital signs
Time frame: Day 1 to Day 7 of each period
Clinical laboratory tests
Time frame: Day 1 to Day 7 of each period
Area under the curve (AUC)
Time frame: Day 1 to Day 7 of each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sotagliflozin (SAR439954) in people with Type 2 Diabetes Mellitus and Healthy Subjects, 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 15 inclusion and 22 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?
Cmax (time frame: Day 1 of each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.