Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients with Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment who have Inadequate Glycemic Control - SOTA-CKD3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004889-26-ES

Enrollment

1800

Registered

2017-07-31

Start date

2017-09-01

Completion date

Unknown

Last updated

2020-02-01

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

Conditions

Type 2 diabetes mellitus Chronic kidney disease stage 3 MedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: LLT Classification code 10076410 Term: Chronic kidney disease stage 3 System Orga

Interventions

Product Name: Sotagliflozin Product Code: SAR439954 Pharmaceutical Form: Tablet INN or Proposed INN: SOTAGLIFLOZIN CAS Number: 1018899-0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with T2D (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an eGFR (based on the 4 variable Modification of Diet in Renal Disease [MDRD] equation) of =30 and =65 years) yes F.1.3.1 Number of subjects for this age range 900

Exclusion criteria

Exclusion criteria: -Hemoglobin A1c (HbA1c) of 11.0%. -Type 1 diabetes. -Women who could become pregnant. -Treatment with an SGLT2 inhbitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months. -Uncontrolled high blood pressure. -Severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes will result in a short life expectancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment; Secondary Objective: -To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight -To evaluate the safety of sotagliflozin dose 1 and dose 2 versus placebo ;Primary end point(s): Change in HbA1c for dose 1 and dose 2;Timepoint(s) of evaluation of this end point: Baseline to Week 26	—

Measure

Time frame

Main Objective: To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment; Secondary Objective: -To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight -To evaluate the safety of sotagliflozin dose 1 and dose 2 versus placebo ;Primary end point(s): Change in HbA1c for dose 1 and dose 2;Timepoint(s) of evaluation of this end point: Baseline to Week 26

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in Fasting Plasma Glucose (FPG) 2. Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg 3. Change in Systolic Blood Pressure (SBP) 4. Change in body weight 5. Change in urinary albumin-to-creatinine ratio (UACR) 6. Patients with HbA1c <6.5% 7. Patients with HbA1c <7.0% 8. Patients with adverse events ; Timepoint(s) of evaluation of this end point: 1. Change in Fasting Plasma Glucose (FPG) : Baseline to Week 26 2. Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg : Baseline to Week 12 3. Change in Systolic Blood Pressure (SBP) : Baseline to Week 12 4. Change in body weight : Baseline to Week 26 5. Change in urinary albumin-to-creatinine ratio (UACR) : Baseline to Week 26 6. Patients with HbA1c <6.5% : Week 26 7. Patients with HbA1c <7.0% : Week 26 8. Patients with adverse events : Week 26	—

Measure

Time frame

Secondary end point(s): 1. Change in Fasting Plasma Glucose (FPG) 2. Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg 3. Change in Systolic Blood Pressure (SBP) 4. Change in body weight 5. Change in urinary albumin-to-creatinine ratio (UACR) 6. Patients with HbA1c <6.5% 7. Patients with HbA1c <7.0% 8. Patients with adverse events ; Timepoint(s) of evaluation of this end point: 1. Change in Fasting Plasma Glucose (FPG) : Baseline to Week 26 2. Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg : Baseline to Week 12 3. Change in Systolic Blood Pressure (SBP) : Baseline to Week 12 4. Change in body weight : Baseline to Week 26 5. Change in urinary albumin-to-creatinine ratio (UACR) : Baseline to Week 26 6. Patients with HbA1c <6.5% : Week 26 7. Patients with HbA1c <7.0% : Week 26 8. Patients with adverse events : Week 26

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Countries

Argentina, Brazil, Canada, Colombia, Germany, Hungary, Israel, Italy, Mexico, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United States

Contacts

Public ContactUnidad Estudios Clínicos

sanofi-aventis, s.a.

es-unidadestudiosclinicos@sanofi.com93 485 94 00

Outcome results

None listed

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