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

NCT ID: NCT03760965

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2020-04-24

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.

Detailed 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sotagliflozin dose 1

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

Group Type: EXPERIMENTAL

sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

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

Group Type: EXPERIMENTAL

sotagliflozin (SAR439954)

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

placebo

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form: tablet

Route of administration: oral

Interventions

sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

placebo

Pharmaceutical form: tablet

Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Investigational Site Number 1560029

Harbin, , China

Investigational Site Number 1560009

Hohhot, , China

Investigational Site Number 1560014

Huai'an, , China

Investigational Site Number 1560019

Huzhou, , China

Investigational Site Number 1560025

Jining, , China

Investigational Site Number 1560027

Jining, , China

Investigational Site Number 1560012

Luoyang, , China

Investigational Site Number 1560013

Pingxiang, , China

Investigational Site Number 1560034

Qingdao, , China

Investigational Site Number 1560026

Qingdao, , China

Investigational Site Number 1560017

Shanghai, , China

Investigational Site Number 1560016

Shanghai, , China

Investigational Site Number 1560006

Shijiazhuang, , China

Investigational Site Number 1560005

Tianjin, , China

Investigational Site Number 1560035

Wuhan, , China

Investigational Site Number 1560023

Xuzhou, , China

Investigational Site Number 1560028

Yinchuan, , China

Investigational Site Number 1560032

Yuncheng, , China

Investigational Site Number 1560015

Zhuzhou, , China

Countries

China

Other Identifiers

U1111-1195-6181

Identifier Type: OTHER

Identifier Source: secondary_id

EFC15194

Identifier Type: -

Identifier Source: org_study_id