Type 1 Diabetes MellitusPhase 1NCT03310944
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
A Phase 1 study testing sotagliflozin (SAR439954) in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in healthy 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 1 Diabetes Mellitus, 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
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 18 Oct 2017to 8 Dec 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 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 32.0 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:
- 95 mmHg <systolic blood pressure (SBP) <140 mmHg,
- 45 mmHg <diastolic blood pressure (DBP) <90 mmHg,
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- 40 bpm <heart rate (HR) <100 bpm.
- Standard 12-lead electrocardiogram 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 and QTc≤450 ms if female with normal electrocardiogram (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 international normalized ratio (INR) should not exceed the upper laboratory norm. Activated partial thromboplastin time (aPTT) should not exceed normal control more than 10 seconds. Total bilirubin out of normal range can be acceptable if total bilirubin should not exceed 1.5 the upper limit with normal conjugated bilirubin values (unless the subject has documented Gilbert syndrome).
- 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 1 of the following contraceptive options: (1) intrauterine device; (2) condom or diaphragm or cervical/vault cap, in addition to spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma follicle-stimulating hormone (FSH) level >30 IU/L. Hormonal contraception is NOT acceptable in this study due to drug interaction.
- Having given written informed consent prior to undertaking any study-related procedure.
- Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
- 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 (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.
- Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.
- Male subject has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- History of renal disease, or significant abnormal kidney function test with glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- 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, unable to stop smoking during the study.
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- Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)
- If female, pregnancy (defined as positive β-HCG blood test if applicable), breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- Any oral contraceptives during the screening period or for at least 15 days prior to inclusion; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to inclusion; or topical controlled delivery contraceptives (patch) for 3 months prior to inclusion.
- Any subject in the exclusion period of a previous study according to applicable regulations.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) 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 embolism or a recurrent or frequent appearance of deep leg 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.
About this study
Official title: An Open-label, Randomized, Single-dose, 4-period, 4-sequence Crossover Relative Bioavailability Study Comparing Sotagliflozin Prototypes Tablets With Reference Tablet in Healthy Subjects
Primary Objective:
To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in healthy subjects.
Read more
Secondary Objectives:
- To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and of the reference formulation in fasted conditions in healthy subjects.
- To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in fasted conditions in healthy subjects.
Read the detailed description
Total duration is 37 to 75 days for each subject, with 2 to 21 days screening period; 4 dosing days, i.e. one in each of the 4 treatment periods. Observation period in each treatment period is 6 days. Washout between dosing days is 7 to 10 days. Follow-up visit is 14-21 days after last dosing.
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Being tested
- sotagliflozin (SAR439954)
- Medical subject headings
- Diabetes Mellitus, Type 1, 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: tablets
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Sotagliflozin dose 1 (reference formulation) | Active comparator | Single oral dose on Day 1 of one of the four period in fasting condition Receives: Drug: sotagliflozin (SAR439954) |
| Sotagliflozin dose 2 (prototype p1 formulation) | Experimental | Single oral dose on Day 1 of one of the four period in fasting condition Receives: Drug: sotagliflozin (SAR439954) |
| Sotagliflozin dose 3 (prototype p2 formulation) | Experimental | Single oral dose on Day 1 of one of the four period in fasting condition Receives: Drug: sotagliflozin (SAR439954) |
| Sotagliflozin dose 4 (prototype p3 formulation) | Experimental | Single oral dose on Day 1 of one of the four period in fasting condition Receives: Drug: sotagliflozin (SAR439954) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pharmacokinetic (PK) Parameter: AUC
Sotagliflozin: Area under the concentration-time curve from 0 to infinity (AUC) for reference, p1, p2, and p3 formulations
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration for reference, p1, p2, and p3 formulations
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Maximum plasma concentration (Cmax)
Sotagliflozin: Maximum plasma concentration (Cmax) for reference, p1, p2, and p3 formulations
Measured: From 0 to 144 hours after IMP intake
Secondary outcomes (10)
Assessment of PK Parameter: Tmax
Sotagliflozin: Time to reach maximum plasma concentration (Tmax)
Measured: From 0 to 144 hours after investigational medicinal product (IMP) intake
Assessment of PK Parameter: Time to reach AUClast (Tlast)
Sotagliflozin: Time to reach AUClast
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Terminal elimination half-life (t1/2)
Sotagliflozin: Terminal elimination half-life (t1/2)
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Tmax
Sotagliflozin 3-O-glucuronide: Tmax
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Tlast
Sotagliflozin 3-O-glucuronide: Time to reach AUClast
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: t1/2
Sotagliflozin 3-O-glucuronide: t1/2
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Cmax
Sotagliflozin 3-O-glucuronide: Cmax
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: AUC
Sotagliflozin 3-O-glucuronide: AUC
Measured: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: AUClast
Sotagliflozin 3-O-glucuronide: AUClast
Measured: From 0 to 144 hours after IMP intake
Adverse Events
Number of patients with treatment emergent adverse events (serious and non-serious)
Measured: Up to 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start18 Oct 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03310944
- Sponsor's protocol ID
- BDR14994
- Other IDs
- 2017-002104-27, U1111-1195-6292, 2017
- Status last verified
- Apr 2022
- First submitted
- 11 Oct 2017
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, 4-period, 4-sequence Crossover Relative Bioavailability Study Comparing Sotagliflozin Prototypes Tablets With Reference Tablet in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03310944
- Acronym / sponsor ID
- BDR14994
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 16 Oct 2017 (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 assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in healthy subjects.
Secondary Objectives:
- To assess the pharmacokinetic characteristics of sotagliflozin and its 3-O-glucuronide following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and of the reference formulation in fasted conditions in healthy subjects.
- To assess the clinical and laboratory safety of single oral doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 and the reference tablet formulation in fasted conditions in healthy subjects.
Detailed description
Total duration is 37 to 75 days for each subject, with 2 to 21 days screening period; 4 dosing days, i.e. one in each of the 4 treatment periods. Observation period in each treatment period is 6 days. Washout between dosing days is 7 to 10 days. Follow-up visit is 14-21 days after last dosing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin dose 1 (reference formulation) | Active comparator | Drug: sotagliflozin (SAR439954)Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin dose 2 (prototype p1 formulation) | Experimental | Drug: sotagliflozin (SAR439954)Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin dose 3 (prototype p2 formulation) | Experimental | Drug: sotagliflozin (SAR439954)Single oral dose on Day 1 of one of the four period in fasting condition |
| Sotagliflozin dose 4 (prototype p3 formulation) | Experimental | Drug: sotagliflozin (SAR439954)Single oral dose on Day 1 of one of the four period in fasting condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 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 32.0 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:
- 95 mmHg <systolic blood pressure (SBP) <140 mmHg,
Key exclusion criteria (18 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- History of renal disease, or significant abnormal kidney function test with glomerular filtration rate (GFR) <90 mL/min as calculated using the Cockcroft-Gault equation.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
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: tablets Route of administration: oral | Drug | Sotagliflozin dose 1 (reference formulation), Sotagliflozin dose 2 (prototype p1 formulation), Sotagliflozin dose 3 (prototype p2 formulation), Sotagliflozin dose 4 (prototype p3 formulation) |
Primary outcome
Assessment of Pharmacokinetic (PK) Parameter: AUC
Time frame: From 0 to 144 hours after IMP intake
Sotagliflozin: Area under the concentration-time curve from 0 to infinity (AUC) for reference, p1, p2, and p3 formulations
Assessment of PK Parameter: Area under the concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time frame: From 0 to 144 hours after IMP intake
Sotagliflozin: Area under the concentration-time curve from 0 to last quantifiable concentration for reference, p1, p2, and p3 formulations
Assessment of PK Parameter: Maximum plasma concentration (Cmax)
Time frame: From 0 to 144 hours after IMP intake
Sotagliflozin: Maximum plasma concentration (Cmax) for reference, p1, p2, and p3 formulations
10 secondary outcomes
Assessment of PK Parameter: Tmax
Time frame: From 0 to 144 hours after investigational medicinal product (IMP) intake
Assessment of PK Parameter: Time to reach AUClast (Tlast)
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Terminal elimination half-life (t1/2)
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Tmax
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Tlast
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: t1/2
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: Cmax
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: AUC
Time frame: From 0 to 144 hours after IMP intake
Assessment of PK Parameter: AUClast
Time frame: From 0 to 144 hours after IMP intake
Adverse Events
Time frame: Up to 75 days
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 13 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 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
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 16 inclusion and 18 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 13 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 Germany. 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 Pharmacokinetic (PK) Parameter: AUC (time frame: From 0 to 144 hours after IMP 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?
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 13 Apr 2022.