Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise

Sponsor
Sanofi
Study ID
NCT03760965
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sotagliflozin (SAR439954) — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • placebo — DRUG
    Pharmaceutical form: tablet Route of administration: oral

Study Details

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.

Key Dates

Start date
Nov 27, 2018
Status verified
Apr 2022
Primary completion
Apr 24, 2020
Completion
Apr 24, 2020

Study Design

Enrollment
276 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sotagliflozin dose 1
    Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
  • Experimental: Sotagliflozin dose 2
    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
  • Placebo Comparator: Placebo
    Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day

Primary Outcome Measure

Change in hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 24 ]

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