Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise
Status and phase
Terminated
Phase 3
Conditions
Type 2 Diabetes Mellitus
Treatments
Drug: sotagliflozin (SAR439954)
Drug: placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
Primary Objective:
To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on diet and exercise.
Secondary Objectives:
- To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight.
- To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight.
- To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg.
- To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.
Full description
Total study duration is up to 30 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect safety information.
Enrollment
276 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Inclusion criteria :
- Chinese patients with Type 2 Diabetes who are treated with diet and exercise only during the 12 weeks prior to screening
- Signed written informed consent.
Exclusion criteria:
- Age <18 years at the screening visit.
- Type 1 diabetes.
- Hemoglobin A1c <7% or >10% 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 medication(s) for >4 months at any time or previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).
- Previous use of any antidiabetic drug within 12 weeks prior to the screening visit.
- 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.
- Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure (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.
- 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.
- 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
276 participants in 3 patient groups, including a placebo group
Sotagliflozin dose 1
Experimental group
Description:
Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
Treatment:
Drug: sotagliflozin (SAR439954)
Sotagliflozin dose 2
Experimental group
Description:
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
Treatment:
Drug: sotagliflozin (SAR439954)
Drug: placebo
Placebo
Placebo Comparator group
Description:
Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Treatment:
Drug: placebo
Trial contacts and locations
29
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Data sourced from clinicaltrials.gov
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