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

NCT03760965 | Terminated Phase 3

• 2 other identifiers: EFC15194U1111-1195-6181
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c (HbA1c)

  Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose1)

  Baseline to Week 24

Secondary Outcomes (7)

• Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT)

  Baseline to Week 24

• Change in fasting plasma glucose (FPG)

  Baseline to Week 24

• Change in body weight

  Baseline to Week 24

• Change in HbA1c

  Baseline to Week 24

• Change in systolic blood pressure (SBP) for all patients

  Baseline to Week 12

Study Arms (3)

Sotagliflozin dose 1

EXPERIMENTAL

Sotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day

Drug: sotagliflozin (SAR439954)

Sotagliflozin dose 2

EXPERIMENTAL

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

Drug: sotagliflozin (SAR439954); Drug: placebo

Placebo

PLACEBO COMPARATOR

Two sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day

Drug: placebo

Interventions

sotagliflozin (SAR439954) DRUG

Pharmaceutical form: tablet Route of administration: oral

Sotagliflozin dose 1; Sotagliflozin dose 2

placebo DRUG

Pharmaceutical form: tablet Route of administration: oral

Placebo; Sotagliflozin dose 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (29)

Investigational Site Number 1560001

Beijing, 100044, China

Location

Investigational Site Number 1560003

Beijing, 100730, China

Location

Investigational Site Number 1560004

Beijing, 100730, China

Location

Investigational Site Number 1560002

Beijing, 101200, China

Location

Investigational Site Number 1560007

Changchun, 130021, China

Location

Investigational Site Number 1560008

Changchun, 130041, China

Location

Investigational Site Number 1560024

Chongqing, 400010, China

Location

Investigational Site Number 1560022

Guangzhou, 510120, China

Location

Investigational Site Number 1560033

Guangzhou, 510150, China

Location

Investigational Site Number 1560021

Guangzhou, China

Location

Investigational Site Number 1560029

Harbin, 150001, China

Location

Investigational Site Number 1560009

Hohhot, 010017, China

Location

Investigational Site Number 1560014

Huai'an, 223300, China

Location

Investigational Site Number 1560019

Huzhou, China

Location

Investigational Site Number 1560025

Jining, China

Location

Investigational Site Number 1560027

Jining, China

Location

Investigational Site Number 1560012

Luoyang, China

Location

Investigational Site Number 1560013

Pingxiang, 337055, China

Location

Investigational Site Number 1560034

Qingdao, 266011, China

Location

Investigational Site Number 1560026

Qingdao, 266042, China

Location

Investigational Site Number 1560017

Shanghai, 200040, China

Location

Investigational Site Number 1560016

Shanghai, China

Location

Investigational Site Number 1560006

Shijiazhuang, China

Location

Investigational Site Number 1560005

Tianjin, 300211, China

Location

Investigational Site Number 1560035

Wuhan, 430000, China

Location

Investigational Site Number 1560023

Xuzhou, 221006, China

Location

Investigational Site Number 1560028

Yinchuan, 750004, China

Location

Investigational Site Number 1560032

Yuncheng, 044000, China

Location

Investigational Site Number 1560015

Zhuzhou, 412007, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: November 27, 2018
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (29)