Type 2 diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 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: -Patients with Type 2 Diabetes on Dipeptidyl peptidase-4 inhibitors(DPP4(i)) with or without metformin at a stable dose for at least 12 weeks prior to Screening Visit. Metformin dose will be =1500 mg per day (or maximum tolerated dose [documented]). DPP4(i) dose must be the appropriate dose as per local label. -Signed written informed consent. 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 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: -Body mass index (BMI) =20 kg/m² or >45 kg/m² at Screening. -Use of any antidiabetic drug other than DPP4 inhibitors and metformin within 12 weeks preceding the Screening Visit. -Patients who have previously participated in any clinical trial of sotagliflozin/LX4211. -Use of a selective Sodium-glucose co-transporter type 2 (SGLT2) inhibitor (eg, canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to screening visit. -Patients with severe anemia, severe cardiovascular disease (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult. -Current diagnosis of chronic hepatitis and/or other clinically active liver disease requiring treatment. -Patients with contraindication to empagliflozin as per local labeling. -Patients with contraindication to metformin as per local labeling. -Hemoglobin A1c 11.0% at Screening (central laboratory). -Fasting plasma glucose >270 mg/dL (>15.0 mmol/L) measured by the central laboratory at Screening (Visit 1), and confirmed by a repeat test (>270 mg/dL [>15.0 mmol/L]) before Randomization. -Previous use of any types of insulin for >1 month (except for treatment of gestational diabetes). -Pregnant (confirmed by serum pregnancy test at Screening) or breast-feeding women. -Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and follow-up period, or who are unwilling or unable to be tested for pregnancy during the study. -Mean of 3 separate blood pressure (BP) measurements >180 mmHg (systolic blood pressure [SBP]) or >100 mmHg (diastolic blood pressure [DBP]). -History of hypertensive crisis resulting in emergency medical care within 12 weeks prior to Screening Visit. -Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the screening period, and still requiring treatment at randomization; -Laboratory findings with the central laboratory tests at Visit 1: -Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range (ULN); -Total bilirubin >1.5 times the ULN (except in case of Gilbert’s syndrome); -Neutrophils 3 times the ULN; -Patients with renal impairment as defined by the estimated glomerular filtration rate (eGFR) criterion that precludes initiation of empagliflozin as per the approved local label (eg, <45 mL/min/1.73 m2 in US; <60 mL/min/1.73 m2 in EU). -Secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome). -If the patient is on hypertensive medications, the antihypertensive has been changed in the 8 weeks prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on a Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) with or without metformin.;Primary end point(s): Change in HbA1c: Absolute change from baseline to week 26 in Hemoglobin A1 (HbA1c);Timepoint(s) of evaluation of this end point: Baseline to week 26; Secondary Objective: -To demonstrate non-inferiority of sotagliflozin versus empagliflozin on HbA1c reduction. -To demonstrate the superiority of sotagliflozin versus placebo on 2-hour postprandial glucose (PPG) reduction, fasting plasma glucose (FPG) reduction, body weight reduction, on the proportion of patients with HbA1c <6.5% and <7.0%, and on sitting systolic blood pressure (SBP) reduction. -To demonstrate the superiority of sotagliflozin versus empagliflozin on HbA1c reduction and sitting SBP reduction - To evaluate the safety of sotagliflozin versus empagliflozin, and placebo, throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in sitting SBP in patients with SBP =130 mmHg at Baseline : Absolute change from baseline to week 12 in sitting systolic blood pressure (SBP) 2. Change in 2-hour PPG following a MMTT: Absolute change in 2-hour post prandial glucose (PPG) following a mixed meal tolerance test (MMTT) from baseline to week 26 3. Change in FPG: Absolute change in fasting plasma glucose (FPG) from baseline to week 26 4. Change in body weight: Absolute change in body weight from baseline to week 26 5. Change in sitting SBP in all patients: Absolute change from baseline to week 12 in sitting systolic blood pressure (SBP) in all patients 6. Patients with HbA1c <6.5%: Proportion of patients with Hemoglobin A1c (HbA1c) <6.5% at week 26 7. Patients with HbA1c <7.0%: Proportion of patients with Hemoglobin A1c (HbA1c) <7.0% at week 26 ; Timepoint(s) of evaluation of this end point: 1) and 5) Baseline to week 12 2), 3) and 4) Baseline to week 26 6) and 7) At week 26 | — |
Countries
Bulgaria, Canada, Czech Republic, France, Italy, Latvia, Mexico, Russian Federation, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactMedical Information
SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
Outcome results
None listed