Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea
Type 2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion criteria :
- Chinese patients with T2D diagnosed for at least 1 year, who are treated with diet/exercise and:
- Metformin alone at a stable dose ( ≥1500 mg/day or maximum tolerated dose [documented]) for at least 8 weeks before the screening visit OR
- Metformin in combination with sulfonylurea (≥ half maximum-labelled dose or maximum tolerated dose [documented]) each at a stable dose for at least 8 weeks before the screening visit.
- Signed written informed consent.
Exclusion criteria:
- Age <18 years at the screening visit.
- Type 1 diabetes.
- Hemoglobin A1c <7% or >10.5% measured by the central laboratory at the screening visit.
- Fasting plasma glucose >15 mmol/L (>270 mg/dL) measured by the central laboratory at the screening visit and confirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization.
- Body mass index (BMI) ≤20 or >45 kg/m2 at the screening visit.
- Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
- Previous use of any antidiabetic drug other than metformin and sulphonylurea within the 12 weeks prior to the screening visit.
- Previous use of any types of insulin for >1 month within 12 months before screening.
- History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the screening visit.
- History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar coma within 12 weeks prior to the screening visit.
- History of serious hypoglycemia resulting in unconsciousness, seizure or hospitalization within 6 months prior to the screening visit.
- Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure DBP (DBP)).
- History of hypertensive emergency within 12 weeks prior to the screening visit.
- Patients with severe anemia, severe cardiovascular (CV) (including congestive heart failure New York Heart Association (NYHA) 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.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal (ULN) laboratory range.
- Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome).
- Use of systemic glucocorticoids (excluding topical or ophthalmic application, nasal spray, or inhaled forms) for more than 10 consecutive days within 90 days prior to the screening visit.
- Patient who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives prior to the screening visit, whichever is longer.
- Use of a selective SGLT2 inhibitor (eg, canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the screening visit.
- Pregnant (confirmed by serum pregnancy test at the screening visit) or breastfeeding women.
- Patients with severe renal disease as defined by an eGFR of <30 mL/min/1.73m² at the screening visit, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
- Patients with contraindication to metformin as per local labelling.
- Patients with contraindication to sulfonylurea as per local labelling if the patient is taking metformin with sulfonylurea.
- Patient unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
- Patients unable to consume at least 50% of the standard meal during the MMTT at baseline (Day 1, Visit 3) before randomization.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 1560039
- Investigational Site Number 1560040
- Investigational Site Number 1560001
- Investigational Site Number 1560038
- Investigational Site Number 1560035
- Investigational Site Number 1560020
- Investigational Site Number 1560012
- Investigational Site Number 1560011
- Investigational Site Number 1560021
- Investigational Site Number 1560024
- Investigational Site Number 1560028
- Investigational Site Number 1560010
- Investigational Site Number 1560036
- Investigational Site Number 1560030
- Investigational Site Number 1560032
- Investigational Site Number 1560027
- Investigational Site Number 1560041
- Investigational Site Number 1560046
- Investigational Site Number 1560009
- Investigational Site Number 1560025
- Investigational Site Number 1560026
- Investigational Site Number 1560006
- Investigational Site Number 1560033
- Investigational Site Number 1560034
- Investigational Site Number 1560014
- Investigational Site Number 1560018
- Investigational Site Number 1560003
- Investigational Site Number 1560004
- Investigational Site Number 1560013
- Investigational Site Number 1560005
- Investigational Site Number 1560019
- Investigational Site Number 1560017
- Investigational Site Number 1560022
- Investigational Site Number 1560023
- Investigational Site Number 1560015
- Investigational Site Number 1560043
- Investigational Site Number 1560042
- Investigational Site Number 1560007
- Investigational Site Number 1560037
- Investigational Site Number 1560016
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Sotagliflozin dose 1
Sotagliflozin dose 2
Placebo
Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
Sotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day