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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
276
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number 1560001
Beijing, China
Investigational Site Number 1560003
Beijing, China
Investigational Site Number 1560004
Beijing, China
Investigational Site Number 1560002
Beijing, China
Investigational Site Number 1560007
Changchun, China
Investigational Site Number 1560008
Changchun, China
Investigational Site Number 1560024
Chongqing, China
Investigational Site Number 1560022
Guangzhou, China
Investigational Site Number 1560033
Guangzhou, China
Investigational Site Number 1560021
Guangzhou, China
...and 19 more locations
Change in hemoglobin A1c (HbA1c)
Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose1)
Time frame: Baseline to Week 24
Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT)
Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2)
Time frame: Baseline to Week 24
Change in fasting plasma glucose (FPG)
Absolute change from baseline to week 24 in FPG (for sotagliflozin dose1 and 2)
Time frame: Baseline to Week 24
Change in body weight
Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2)
Time frame: Baseline to Week 24
Change in HbA1c
Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2)
Time frame: Baseline to Week 24
Change in systolic blood pressure (SBP) for all patients
Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose1 and 2)
Time frame: Baseline to Week 12
Change in SBP for patients with baseline SBP ≥130 mmHg
Absolute change from baseline to week 12 in SBP patients with baseline SBP ≥130 mmHg (for sotagliflozin dose1 and 2)
Time frame: Baseline to Week 12
Adverse events
Number of patients with adverse events
Time frame: Up to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.