Diabetes MellitusPhase 2NCT03462069
Comparison of Pharmacodynamic Effects of Sotagliflozin and Empagliflozin in T2DM Patients With Mild to Moderate Hypertension
A Phase 2 study testing Sotagliflozin (SAR439954) and Empagliflozin in people with Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an angiotensin converting… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sotagliflozin (SAR439954) and Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 12 Mar 2018to 18 Apr 2019
- Phase
- Phase 2
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with Type 2 Diabetes Mellitus (T2DM) (diagnosed at least 1 year before screening visit), between 18 and 74 years of age, inclusive, with:
- Hypertension grades 1 or 2 as defined by the European Society of Hypertension (ESH)/European Society of Cardiology (ESC) at screening; systolic blood pressure (SBP) has to be in the range of 140-179 mmHg (after 10 minutes resting in supine position, measurement in triplicate with each measurement to be within this range at screening). If the blood pressure (BP) range is not met at screening, one repeat measurement at another occasion is allowed prior to inclusion into the study.
- Glycated Haemoglobin A1c (HbA1c) at screening between 6.5% and 11%.
- On a stable treatment with metformin, i.e., no change in dose regimen or in dose levels in the last 3 months prior to screening and throughout the study.
- On a stable treatment with an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker, i.e., no change in dose regimen or in dose levels in the last 4 weeks prior to screening and until randomization.
- On a stable treatment with an ACE inhibitor or an angiotensin receptor blocker after switching from beta-blockers and/or thiazides for eligible patients after screening, i.e., no change in dose regimen and in dose levels in the last 4 weeks prior to run-in phase and until randomization
- Body weight between 50.0 kg and 130 kg, inclusive, if male, and between 40.0 kg and 110 kg, inclusive, if female, body mass index between 18.0 and 38.0 kg/m2, inclusive.
- Kidney function: Estimated glomerular filtration rate at screening must be 60 mL/min/1.73m2 or higher.
Who cannot join
- Patients with severe anemia, severe cardiovascular, gastrointestinal, respiratory, neurological, osteomuscular, psychiatric, or active malignant tumor or other major systemic disease or patients with infectious disease, signs of acute illness, or short life expectancy making implementation of the protocol or interpretation of the study results difficult (as evaluated by detailed medical history and complete physical and laboratory examination).
- Heart failure New York Heart Association (NYHA) Classification III/IV.
- Any clinically significant abnormality in echocardiography performed at screening as judged by the investigator based on age, gender and medical history of the individual patient.
- History of myocardial infarction within the last 12 months prior to screening.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., long-term systemic glucocorticoids) and refusing or unable to take alternative treatment.
- Type 1 diabetes mellitus.
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- Secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
- Clinically significant pulmonary hypertension, in particular World Health Organisation (WHO) Classes IV (Pulmonary hypertension due to chronic thrombotic and/or embolic disease [CTEPH]) and V (miscellaneous).
- Diabetic retinopathy.
- History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
- History of severe hypoglycemia resulting in hospitalization or unconsciousness/seizures within 6 months prior to the Screening visit.
- History of prior gastric or intestinal surgical procedure including gastric banding within 3 years before the Screening Visit. Any gastrointestinal surgery with removal of part of the bowels or the stomach
- History of unexplained pancreatitis, chronic pancreatitis, stomach/gastric surgery, inflammatory bowel disease.
- Known hypersensitivity to sotagliflozin, empagliflozin or any excipient of the drug products.
- 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: A Randomized, Double-blind, Parallel-group, 2-treatment Multiple Dose Study to Assess the Intestinal, Metabolic and Cardiovascular Effects of an 8 Weeks Treatment With Sotagliflozin QD as Compared With Empagliflozin Once a Day (QD) in Type 2 Diabetes Mellitus (T2DM) Patients With Mild to Moderate Hypertension
Primary Objective:
To compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an angiotensin converting enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) under standardized diet conditions.
Read more
Secondary Objectives:
- To compare the renal and cardiovascular PD effects of an 8 weeks treatment with sotagliflozin QD to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an ACE inhibitor or ARB.
- To evaluate the safety and tolerability of an 8 weeks QD treatment with sotagliflozin or empagliflozin in mild to moderate hypertensive T2DM patients on a stable treatment with metformin and an ACE inhibitor or ARB.
- To evaluate the pharmacokinetic (PK) profile of sotagliflozin in steady state conditions.
Read the detailed description
The total study duration per patient is 70-105 days (for patients without drug washout/switch period), and up to 175 days (for patients with drug washout/switch period), including 2-30 days of screening, 5 days of run-in period, 56 days of treatment period, and a 7-14 days of follow-up period.
- Conditions
- Diabetes Mellitus
- Being tested
- Sotagliflozin (SAR439954), Placebo, Empagliflozin
- Medical subject headings
- Diabetes Mellitus
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
PlaceboDrug
Pharmaceutical form: tablet
Route of administration: oral
EmpagliflozinDrug
Also called Jardiance®
Pharmaceutical form: capsule
Route of administration: oral
PlaceboDrug
Pharmaceutical form: capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Test) | Experimental | Sotagliflozin 2 tablets administered once daily with 1 empagliflozin placebo capsule prior to the first meal of the day Receives: Drug: Sotagliflozin (SAR439954); Drug: Placebo |
| Treatment B (Reference) | Active comparator | Empagliflozin 1 capsule administered once daily with 2 sotagliflozin placebo tablets prior to the first meal of the day Receives: Drug: Placebo; Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacodynamic (PD) parameters in feces
Change from baseline in fecal sodium excretion
Measured: Baseline and on Day 55 and 56 (over 48 hours)
Assessment of pharmacodynamic (PD) parameters in feces
Change from baseline in fecal short-chain fatty acids (SCFA)
Measured: Baseline and on Day 55 and 56 (over 48 hours)
Assessment of pharmacodynamic (PD) parameters in feces
Change from baseline in fecal pH
Measured: Baseline and on Day 55 and 56 (over 48 hours)
Assessment of PD parameters in urine
Change from baseline in 24-hour urinary glucose excretion
Measured: Baseline and on Day 56 (over 24 hours)
Assessment of PD parameters in urine
Change from baseline in 24-hour sodium excretion
Measured: Baseline and on Day 56 (over 24 hours)
Assessment of PD parameters in blood
14 hour plasma glucose profile after standardized meals
Measured: Baseline and on Day 56
Assessment of PD parameters in blood
14 hour plasma glucagon-like peptide 1 (GLP-1) profile after standardized meals
Measured: Baseline and on Day 56
Secondary outcomes (13)
Fasting metabolic laboratory panel
Change from baseline in fasting plasma glucose
Measured: Baseline and on Day 56
Ambulatory Blood Pressure Measurement (ABPM)
Change from baseline in average 24h systolic arterial pressure
Measured: Baseline and on days 54 until Day 56
Cardiovascular parameters
Change from baseline in plasma aldosterone
Measured: Baseline and on Day 56
Pulse wave velocity
Change from baseline in carotid-femoral pulse wave velocity
Measured: Baseline and on Day 55
Continuous Glucose Monitoring (CGM)
Change from baseline in average diurnal glucose
Measured: Baseline, last 3 days of treatment
Echocardiography
Change from baseline in left ventricular ejection fraction (LVEF)
Measured: Baseline and on Day 54
Echocardiography
Change from baseline in left ventricular end-diastolic diameter
Measured: Baseline and on Day 54
Plasma Volume Measurement
Change from baseline in plasma volume
Measured: Baseline and on Day 54
Adverse events
Number of patients with reported adverse events
Measured: Over 15 weeks
Assessment of pharmacokinetic (PK) parameters: Cmax
Sotagliflozin: maximum plasma concentration observed (Cmax)
Measured: 24 hours after last investigational medicinal product (IMP) administration
Assessment of pharmacokinetic (PK) parameters: Ctrough
Sotagliflozin: plasma concentration observed before administration during repeated dosing (Ctrough)
Measured: 24 hours after last IMP administration
Assessment of pharmacokinetic (PK) parameters: AUCtau
Sotagliflozin: Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (AUCtau)
Measured: 24 hours after last IMP administration
Assessment of pharmacokinetic (PK) parameters: tmax
Sotagliflozin: First time to reach Cmax (tmax)
Measured: 24 hours after last IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start12 Mar 2018
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 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
- NCT03462069
- Sponsor's protocol ID
- PDY15010
- Other IDs
- 2017-002309-36, U1111-1186-2962, 2017
- Status last verified
- Apr 2022
- First submitted
- 6 Mar 2018
- Last updated
- 25 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
Publications
Posch MG, Walther N, Ferrannini E, Powell DR, Banks P, Wason S, Dahmen R. Metabolic, Intestinal, and Cardiovascular Effects of Sotagliflozin Compared With Empagliflozin in Patients With Type 2 Diabetes: A Randomized, Double-Blind Study. Diabetes Care. 2022 Sep 1;45(9):2118-2126. doi: 10.2337/dc21-2166.
PubMed 35817022
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 Randomized, Double-blind, Parallel-group, 2-treatment Multiple Dose Study to Assess the Intestinal, Metabolic and Cardiovascular Effects of an 8 Weeks Treatment With Sotagliflozin QD as Compared With Empagliflozin Once a Day (QD) in Type 2 Diabetes Mellitus (T2DM) Patients With Mild to Moderate Hypertension
- ClinicalTrials.gov ID
- NCT03462069
- Acronym / sponsor ID
- PDY15010
- Conditions
- Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 12 Mar 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 compare the metabolic and gastrointestinal pharmacodynamic (PD) effects of an 8 weeks treatment with sotagliflozin once daily (QD) to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an angiotensin converting enzyme (ACE) inhibitor or Angiotensin Receptor Blocker (ARB) under standardized diet conditions.
Secondary Objectives:
- To compare the renal and cardiovascular PD effects of an 8 weeks treatment with sotagliflozin QD to an 8 weeks treatment to empagliflozin QD in mild or moderate hypertensive T2DM patients on a stable treatment regimen with metformin and an ACE inhibitor or ARB.
- To evaluate the safety and tolerability of an 8 weeks QD treatment with sotagliflozin or empagliflozin in mild to moderate hypertensive T2DM patients on a stable treatment with metformin and an ACE inhibitor or ARB.
- To evaluate the pharmacokinetic (PK) profile of sotagliflozin in steady state conditions.
Detailed description
The total study duration per patient is 70-105 days (for patients without drug washout/switch period), and up to 175 days (for patients with drug washout/switch period), including 2-30 days of screening, 5 days of run-in period, 56 days of treatment period, and a 7-14 days of follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Test) | Experimental | Drug: Sotagliflozin (SAR439954), Drug: PlaceboSotagliflozin 2 tablets administered once daily with 1 empagliflozin placebo capsule prior to the first meal of the day |
| Treatment B (Reference) | Active comparator | Drug: Placebo, Drug: EmpagliflozinEmpagliflozin 1 capsule administered once daily with 2 sotagliflozin placebo tablets prior to the first meal of the day |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients with Type 2 Diabetes Mellitus (T2DM) (diagnosed at least 1 year before screening visit), between 18 and 74 years of age, inclusive, with:
- On a stable treatment with metformin, i.e., no change in dose regimen or in dose levels in the last 3 months prior to screening and throughout the study.
- On a stable treatment with an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker, i.e., no change in dose regimen or in dose levels in the last 4 weeks prior to screening and until randomization.
- On a stable treatment with an ACE inhibitor or an angiotensin receptor blocker after switching from beta-blockers and/or thiazides for eligible patients after screening, i.e., no change in dose regimen and in dose levels in the last 4 weeks prior to run-in phase and until randomization
- Body weight between 50.0 kg and 130 kg, inclusive, if male, and between 40.0 kg and 110 kg, inclusive, if female, body mass index between 18.0 and 38.0 kg/m2, inclusive.
Key exclusion criteria (15 listed)
- Patients with severe anemia, severe cardiovascular, gastrointestinal, respiratory, neurological, osteomuscular, psychiatric, or active malignant tumor or other major systemic disease or patients with infectious disease, signs of acute illness, or short life expectancy making implementation of the protocol or interpretation of the study results difficult (as evaluated by detailed medical history and complete physical and laboratory examination).
- Heart failure New York Heart Association (NYHA) Classification III/IV.
- Any clinically significant abnormality in echocardiography performed at screening as judged by the investigator based on age, gender and medical history of the individual patient.
- History of myocardial infarction within the last 12 months prior to screening.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g., long-term systemic glucocorticoids) and refusing or unable to take alternative treatment.
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 | Treatment A (Test) |
| PlaceboPharmaceutical form: tablet Route of administration: oral | Drug | Treatment B (Reference) |
| EmpagliflozinAlso: Jardiance®Pharmaceutical form: capsule Route of administration: oral | Drug | Treatment B (Reference) |
| PlaceboPharmaceutical form: capsule Route of administration: oral | Drug | Treatment A (Test) |
Primary outcome
Assessment of pharmacodynamic (PD) parameters in feces
Time frame: Baseline and on Day 55 and 56 (over 48 hours)
Change from baseline in fecal sodium excretion
Assessment of pharmacodynamic (PD) parameters in feces
Time frame: Baseline and on Day 55 and 56 (over 48 hours)
Change from baseline in fecal short-chain fatty acids (SCFA)
Assessment of pharmacodynamic (PD) parameters in feces
Time frame: Baseline and on Day 55 and 56 (over 48 hours)
Change from baseline in fecal pH
Assessment of PD parameters in urine
Time frame: Baseline and on Day 56 (over 24 hours)
Change from baseline in 24-hour urinary glucose excretion
Assessment of PD parameters in urine
Time frame: Baseline and on Day 56 (over 24 hours)
Change from baseline in 24-hour sodium excretion
Assessment of PD parameters in blood
Time frame: Baseline and on Day 56
14 hour plasma glucose profile after standardized meals
Assessment of PD parameters in blood
Time frame: Baseline and on Day 56
14 hour plasma glucagon-like peptide 1 (GLP-1) profile after standardized meals
13 secondary outcomes
Fasting metabolic laboratory panel
Time frame: Baseline and on Day 56
Ambulatory Blood Pressure Measurement (ABPM)
Time frame: Baseline and on days 54 until Day 56
Cardiovascular parameters
Time frame: Baseline and on Day 56
Pulse wave velocity
Time frame: Baseline and on Day 55
Continuous Glucose Monitoring (CGM)
Time frame: Baseline, last 3 days of treatment
Echocardiography
Time frame: Baseline and on Day 54
Echocardiography
Time frame: Baseline and on Day 54
Plasma Volume Measurement
Time frame: Baseline and on Day 54
Adverse events
Time frame: Over 15 weeks
Assessment of pharmacokinetic (PK) parameters: Cmax
Time frame: 24 hours after last investigational medicinal product (IMP) administration
Assessment of pharmacokinetic (PK) parameters: Ctrough
Time frame: 24 hours after last IMP administration
Assessment of pharmacokinetic (PK) parameters: AUCtau
Time frame: 24 hours after last IMP administration
Assessment of pharmacokinetic (PK) parameters: tmax
Time frame: 24 hours after last IMP administration
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.
- Derived from this study: PubMed 35817022Posch MG, Walther N, Ferrannini E, Powell DR, Banks P, Wason S, Dahmen R. Metabolic, Intestinal, and Cardiovascular Effects of Sotagliflozin Compared With Empagliflozin in Patients With Type 2 Diabetes: A Randomized, Double-Blind Study. Diabetes Care. 2022 Sep 1;45(9):2118-2126. doi: 10.2337/dc21-2166.
- 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 2 study testing Sotagliflozin (SAR439954) and Empagliflozin in people with 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 8 inclusion and 15 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 pharmacodynamic (PD) parameters in feces (time frame: Baseline and on Day 55 and 56 (over 48 hours)). The study lists 7 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 NCT03462069, which also lists 1 linked publication.
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.