A Phase 1 interventional study of Sotagliflozin (SAR439954) and Hydrochlorothiazide in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 1, Interventional, and Treatment
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Among 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2 — 2 open to participants now, 2 under way, none of them phase 3. sotagliflozin · Diabetes Mellitus, Type 2.
Among the 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2, this one is the 24th largest by enrollment, is one of 5 that started in 2018, is one of 10 in phase 1, and was the 19th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →2 of the 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2 are open now, in 1 country. Recruiting first, the newest first:
Baylor Research Institute · Sites in United States
Ages 18–84
AdventHealth Translational Research Institute · Sites in United States
Ages 18–40 · Healthy volunteers
By country, each count listing its studies:
sotagliflozin: first FDA approval 2023 (INPEFA), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
27 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 276 across the 27 interventional studies. Of the 25 that completed or were terminated, 13 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 27 have an industry lead sponsor. The 4 most frequent:
Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
186 studies in Diabetes Mellitus, Type 2 by Sanofi: 1 open now, 1 under way, none of them phase 3. Of 183 finished, 46 (25%) have results posted.
Among the 186 studies in Diabetes Mellitus, Type 2 by Sanofi, this one is the 166th largest by enrollment of the 178 interventional ones that give a count, is one of 12 that started in 2018, is one of 16 in phase 1, and was the 158th registered.
Sanofi’s Diabetes Mellitus, Type 2 studies by the year they started, since 2000.
None of the studies under way reaches primary completion within a year.
Among the 27 studies testing sotagliflozin in Diabetes Mellitus, Type 2, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Sanofi’s 186 in Diabetes Mellitus, Type 2:
Nothing recorded among them since 2026-09-25.
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Primary Objective:
To assess the effects of multiple-dose hydrochlorothiazide (HCTZ) on the steady-state pharmacokinetics (PK) of sotagliflozin.
Secondary Objectives:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sotagliflozin (SAR439954) · Drug: Hydrochlorothiazide
Pharmaceutical form: Tablet Route of administration: Oral
Pharmaceutical form: Tablet Route of administration: Oral
Assessment of PK parameter: AUCtau
Sotagliflozin without HCTZ: AUC to the end of the dosing period (AUCtau)
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Sotagliflozin with HCTZ: AUCtau
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: AUCtau
HCTZ without sotagliflozin: AUCtau
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: AUCtau
HCTZ with sotagliflozin: AUCtau
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: AUCtau
Sotagliflozin-3-O-glucuronide without HCTZ: AUCtau
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: AUCtau
Sotagliflozin-3-O-glucuronide with HCTZ: AUCtau
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
HCTZ without sotagliflozin: Maximum plasma concentration (Cmax)
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: Cmax
HCTZ with sotagliflozin: Cmax
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: Cmax
Sotagliflozin-3-O-glucuronide without HCTZ: Cmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Sotagliflozin-3-O-glucuronide with HCTZ: Cmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: tmax
HCTZ without sotagliflozin: Time to reach Cmax (tmax)
Time frame: Period 2, days 4 to 5
Assessment of PK parameter: tmax
HCTZ with sotagliflozin: tmax
Time frame: Period 2, days 9 to 10
Assessment of PK parameter: tmax
Sotagliflozin-3-O-glucuronide without HCTZ: tmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Sotagliflozin-3-O-glucuronide with HCTZ: tmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: Cmax
Sotagliflozin without HCTZ: Cmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: Cmax
Sotagliflozin with HCTZ: Cmax
Time frame: Period 2, days 6 to 10
Assessment of PK parameter: tmax
Sotagliflozin without HCTZ: tmax
Time frame: Period 1, days 2 to 6
Assessment of PK parameter: tmax
Sotagliflozin with HCTZ: tmax
Time frame: Period 2, days 6 to 10
Plan to share: 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
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Mar 2018, 1 month.
Of 453 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 1 month is below that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sotagliflozin · Hydrochlorothiazide