Type 2 Diabetes MellitusPhase 1NCT03387657
A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide
A Phase 1 study testing Sotagliflozin (SAR439954) and Hydrochlorothiazide in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective: To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin. Secondary Objectives: To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ To assess the effects of… 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) and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2018to 2 Mar 2018
- 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
- 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, electrocardiogram, and laboratory parameters.
- 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 level >30 IU. Hormonal contraception is NOT acceptable in this study.
- 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 medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- 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 or alcohol test.
- Any contra-indications to hydrochlorothiazide, according to the applicable labeling.
- 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).
- 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
Dallas, Texas, 75247
About this study
Official title: A Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects
Primary Objective:
To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.
Secondary Objectives:
- To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ
- To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ
- To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Read the detailed description
Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sotagliflozin (SAR439954), Hydrochlorothiazide
- 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
HydrochlorothiazideDrug
Pharmaceutical form: Tablet
Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Sotagliflozin + Hydrochlorothiazide (HCTZ) | Experimental | Sotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days. Receives: Drug: Sotagliflozin (SAR439954); Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of PK parameter: AUCtau
Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)
Measured: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Sotagliflozin with HCTZ: AUCtau
Measured: Period 2, days 6 to 10
Secondary outcomes (16)
Assessment of PK parameter: AUCtau
HCTZ without sotagliflozin: AUCtau
Measured: Period 2, days 4 to 5
Assessment of PK parameter: AUCtau
HCTZ with sotagliflozin: AUCtau
Measured: Period 2, days 9 to 10
Assessment of PK parameter: AUCtau
Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau
Measured: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau
Measured: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)
Measured: Period 2, days 4 to 5
Assessment of PK parameter: Cmax
HCTZ with sotagliflozin: Cmax
Measured: Period 2, days 9 to 10
Assessment of PK parameter: Cmax
Sotagliflozin-3-O-glucuronide without HCTZ: Cmax
Measured: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Sotagliflozin-3-O-glucuronide with HCTZ: Cmax
Measured: Period 2, days 6 to 10
Assessment of PK parameter: tmax
HCTZ without sotagliflozin: Time to reach Cmax (tmax)
Measured: Period 2, days 4 to 5
Assessment of PK parameter: tmax
HCTZ with sotagliflozin: tmax
Measured: Period 2, days 9 to 10
Assessment of PK parameter: tmax
Sotagliflozin-3-O-glucuronide without HCTZ: tmax
Measured: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Sotagliflozin-3-O-glucuronide with HCTZ: tmax
Measured: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
Sotagliflozin without HCTZ: Cmax
Measured: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Sotagliflozin with HCTZ: Cmax
Measured: Period 2, days 6 to 10
Assessment of PK parameter: tmax
Sotagliflozin without HCTZ: tmax
Measured: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Sotagliflozin with HCTZ: tmax
Measured: Period 2, days 6 to 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start3 Jan 2018
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT03387657
- Sponsor's protocol ID
- INT14905
- Other IDs
- U1111-1186-2718
- Status last verified
- Apr 2022
- First submitted
- 20 Dec 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
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 Phase 1, Single-Center, Open-Label, Two-Period, Single-Sequence, Multiple Dosing Drug-Drug Interaction Study of Sotagliflozin and Hydrochlorothiazide in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03387657
- Acronym / sponsor ID
- INT14905
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 2 Jan 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 assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.
Secondary Objectives:
- To assess the safety and tolerability of multiple-dose sotagliflozin with and without co-administration of multiple-dose HCTZ
- To assess the effects of multiple-dose sotagliflozin on the steady-state PK of HCTZ
- To assess the effects of multiple-dose HCTZ on the steady-state PK of sotagliflozin-3-O-glucuronide
Detailed description
Duration of the study for each subject will be between 33 to 77 days, including screening up to 28 days, 5 days of treatment Period 1, washout period of 7-21 days, 9 days of treatment Period 2, and follow-up period of 10-14 days after last dose of the Investigational Medicinal Product (IMP) in Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin + Hydrochlorothiazide (HCTZ) | Experimental | Drug: Sotagliflozin (SAR439954), Drug: HydrochlorothiazideSotagliflozin to be administered alone in Period 1. HCTZ to be given in Period 2 for 4 days followed immediately by HCTZ and sotagliflozin for 5 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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, electrocardiogram, and laboratory parameters.
- 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 level >30 IU. Hormonal contraception is NOT acceptable in this study.
Key exclusion criteria (6 listed)
- Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- 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 or alcohol test.
- Any contra-indications to hydrochlorothiazide, according to the applicable labeling.
- 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).
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 + Hydrochlorothiazide (HCTZ) |
| HydrochlorothiazidePharmaceutical form: Tablet Route of administration: Oral | Drug | Sotagliflozin + Hydrochlorothiazide (HCTZ) |
Primary outcome
Assessment of PK parameter: AUCtau
Time frame: Period 1, days 2 to 6
Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)
Assessment of PK parameter: AUCtau
Time frame: Period 2, days 6 to 10
Sotagliflozin with HCTZ: AUCtau
16 secondary outcomes
Assessment of PK parameter: AUCtau
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: AUCtau
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: AUCtau
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: Cmax
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: Cmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: tmax
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: tmax
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: tmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: tmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Time frame: Period 2, days 6 to 10
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) and Hydrochlorothiazide 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 8 inclusion and 6 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 parameter: AUCtau (time frame: Period 1, days 2 to 6). 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.