Diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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; SBP (systolic blood pressure) 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, ie, no change in dose regimen or in dose levels in the last 3 months 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, ie, 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -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. -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: -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.;Primary end point(s): Assessment of pharmacodynamic (PD) parameters in feces Assessment of PD parameters in urine Assessment of PD parameters in blood;Timepoint(s) of evaluation of this end point: - Assessment of pharmacodynamic (PD) parameters in feces : Baseline and on Day 55 and 56 (over 48 hours) - Assessment of PD parameters in urine Baseline and on Day 56 (over 24 hours) - Assessment of PD parameters in blood Baseline and on Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Fasting metabolic laboratory panel 2 - Ambulatory Blood Pressure Measurement (ABPM) 3 - Cardiovascular parameters 4 - Pulse wave velocity 5 - Continuous Glucose Monitoring (CGM) 6 - Echocardiography 7 - Plasma Volume Measurement 8 - Adverse events 9 - Assessment of pharmacokinetic (PK) parameters: Cmax 10 - Assessment of pharmacokinetic (PK) parameters: Ctrough 11 - Assessment of pharmacokinetic (PK) parameters: AUCtau 12 - Assessment of pharmacokinetic (PK) parameters: tmax;Timepoint(s) of evaluation of this end point: 1 - Fasting metabolic laboratory panel : Baseline and on Day 56 2 - Ambulatory Blood Pressure Measurement (ABPM) : Baseline and on days 54 until Day 56 3 - Cardiovascular parameters : Baseline and on Day 56 4 - Pulse wave velocity : Baseline and on Day 55 5 - Continuous Glucose Monitoring (CGM) : Baseline, last 3 days of treatment 6 - Echocardiography : Baseline and on Day 54 7 - Plasma Volume Measurement : Baseline and on Day 54 8 - Adverse events : Over 15 weeks 24 hours after IMP administration 9 - Assessment of pharmacokinetic (PK) parameters: Cmax 10 - Assessment of pharmacokinetic (PK) parameters: Ctrough 11 - Assessment of pharmacokinetic (PK) parameters: AUCtau 12 - Assessment of pharmacokinetic (PK) parameters: tmax | — |
Countries
Germany
Outcome results
None listed