Efficacy and Safety of Sotagliflozin versus Placebo in Subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control while Taking Insulin Alone or with Other Oral Antidiabetic Agents

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs) - SOTA-INS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001804-43-HU

Enrollment

800

Registered

2017-09-08

Start date

2017-10-19

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Sotagliflozin Product Code: SAR439954 Pharmaceutical Form: Tablet INN or Proposed INN: SOTAGLIFLOZIN CAS Number: 1018899-04-1 Current Sponsor code: SAR439954 Other descriptive name: LX42

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with T2D (Type 2 diabetes) using any types of basal insulin alone or in combination with up to 2 OADs (oral antidiabetic drugs) - Patient has given written informed consent to participate in the study in accordance with local regulations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 640 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160

Exclusion criteria

Exclusion criteria: - At the time of Screening age 10.5% measured by the central laboratory at Screening - HbA1c 180 mmHg (SBP) or >100 mmHg (diastolic blood pressure [DBP]) - History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the Screening Visit - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range - Total bilirubin >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome)

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to HbA1c (glycosylated hemoglobin) reduction in patients with T2D (type 2 diabetes mellitus) who have inadequate glycemic control on basal insulin alone or with OADs (oral antidiabetic drugs).;Secondary Objective: To assess the effects of sotagliflozin dose 1 versus placebo on Fasting Plasma Glucose (FPG), Systolic Blood Pressure (SBP), and body weight To assess the effects of sotagliflozin dose 2 versus placebo on HbA1c, body weight, SBP, and FPG To assess the effects of sotagliflozin dose 1 versus placebo on the proportion of patients with HbA1c <7.0% or HbA1c <6.5% To assess the effects of sotagliflozin dose 2 versus placebo on the proportion of patients with HbA1c <7.0% or HbA1c <6.5% To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo;Primary end point(s): Absolute change from baseline in hemoglobin A1c (HbA1c )(for sotagliflozin dose 1);Timepoint(s) of evaluation of this end point: Baseline to week 18	—

Measure

Time frame

Main Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to HbA1c (glycosylated hemoglobin) reduction in patients with T2D (type 2 diabetes mellitus) who have inadequate glycemic control on basal insulin alone or with OADs (oral antidiabetic drugs).;Secondary Objective: To assess the effects of sotagliflozin dose 1 versus placebo on Fasting Plasma Glucose (FPG), Systolic Blood Pressure (SBP), and body weight To assess the effects of sotagliflozin dose 2 versus placebo on HbA1c, body weight, SBP, and FPG To assess the effects of sotagliflozin dose 1 versus placebo on the proportion of patients with HbA1c <7.0% or HbA1c <6.5% To assess the effects of sotagliflozin dose 2 versus placebo on the proportion of patients with HbA1c <7.0% or HbA1c <6.5% To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo;Primary end point(s): Absolute change from baseline in hemoglobin A1c (HbA1c )(for sotagliflozin dose 1);Timepoint(s) of evaluation of this end point: Baseline to week 18

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Secondary

Measure	Time frame
Secondary end point(s): Baseline to week 18 - Change in FPG (for sotagliflozin dose 1) - Change in Body Weight (for sotagliflozin dose 1) - HbA1c <7.0% (for sotagliflozin dose 1) - HbA1c <6.5% (for sotagliflozin dose 1) - Change in HbA1c (for sotagliflozin dose 2) - Change in FPG (for sotagliflozin dose 2) - Change in BW (for sotagliflozin dose 2) - HbA1c <7.0% (for sotagliflozin dose 2) - HbA1c <6.5% (for sotagliflozin dose 2) Baseline to week 12 - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 1) - Change in SBP for all patients (for sotagliflozin dose 1) - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 2) Up to week 54 Adverse events;Timepoint(s) of evaluation of this end point: Baseline to week 18 - Change in FPG (for sotagliflozin dose 1) - Change in Body Weight (for sotagliflozin dose 1) - HbA1c <7.0% (for sotagliflozin dose 1) - HbA1c <6.5% (for sotagliflozin dose 1) - Change in HbA1c (for sotagliflozin dose 2) - Change in FPG (for sotagliflozin dose 2) - Change in BW (for sotagliflozin dose 2) - HbA1c <7.0% (for sotagliflozin dose 2) - HbA1c <6.5% (for sotagliflozin dose 2) Baseline to week 12 - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 1) - Change in SBP for all patients (for sotagliflozin dose 1) - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 2) Up to week 54 Adverse events	—

Measure

Time frame

Secondary end point(s): Baseline to week 18 - Change in FPG (for sotagliflozin dose 1) - Change in Body Weight (for sotagliflozin dose 1) - HbA1c <7.0% (for sotagliflozin dose 1) - HbA1c <6.5% (for sotagliflozin dose 1) - Change in HbA1c (for sotagliflozin dose 2) - Change in FPG (for sotagliflozin dose 2) - Change in BW (for sotagliflozin dose 2) - HbA1c <7.0% (for sotagliflozin dose 2) - HbA1c <6.5% (for sotagliflozin dose 2) Baseline to week 12 - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 1) - Change in SBP for all patients (for sotagliflozin dose 1) - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 2) Up to week 54 Adverse events;Timepoint(s) of evaluation of this end point: Baseline to week 18 - Change in FPG (for sotagliflozin dose 1) - Change in Body Weight (for sotagliflozin dose 1) - HbA1c <7.0% (for sotagliflozin dose 1) - HbA1c <6.5% (for sotagliflozin dose 1) - Change in HbA1c (for sotagliflozin dose 2) - Change in FPG (for sotagliflozin dose 2) - Change in BW (for sotagliflozin dose 2) - HbA1c <7.0% (for sotagliflozin dose 2) - HbA1c <6.5% (for sotagliflozin dose 2) Baseline to week 12 - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 1) - Change in SBP for all patients (for sotagliflozin dose 1) - Change in SBP for patients with Baseline SBP =130 mmHg (for sotagliflozin dose 2) Up to week 54 Adverse events

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Countries

Bulgaria, Canada, Czech Republic, France, Hungary, Slovakia, United Kingdom, United States

Contacts

Public ContactNA.

sanofi-aventis Zrt.

kapcsolat@sanofi.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026