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Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control (SOTA-CKD3)

Primary Purpose

Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Sotagliflozin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and <60 milliliter per minute (mL/min)/1.73 meter square (m^2) (chronic kidney disease [CKD] 3A, 3B).
Participants has given written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

Hemoglobin A1c (HbA1c) of <7.0% or >11.0%.
Type 1 diabetes.
Women of childbearing potential (WOCBP) 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.
Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months.
Uncontrolled high blood pressure.
Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Sotagliflozin 200 mg

Sotagliflozin 400 mg

Arm Description

Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.

Following a 2-week run-in period, participants received two tablets, 1 sotagliflozin 200 mg tablet and 1 placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 58 weeks.

Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c at Week 26

An Analysis of covariance (ANCOVA) model was used for analysis.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

An ANCOVA model was used for analysis.

Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12

An ANCOVA model was used for analysis.

Change From Baseline in SBP at Week 12 for All Participants

An ANCOVA model was used for analysis.

Change From Baseline in Body Weight at Week 26

An ANCOVA model was used for analysis.

Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)

An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

Percentage of Participants With HbA1c <6.5% at Week 26

Percentage of Participants With HbA1c <7.0% at Week 26

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Full Information

NCT ID

NCT03242252

First Posted

August 3, 2017

Last Updated

June 3, 2021

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03242252

Brief Title

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

Acronym

SOTA-CKD3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

August 16, 2017 (Actual)

Primary Completion Date

March 25, 2019 (Actual)

Study Completion Date

October 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Primary Objective: To demonstrate the superiority of Sotagliflozin 200 milligrams (mg) and Sotagliflozin 400 mg versus placebo on HbA1c reduction at 26 Weeks in participants with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment. Secondary Objectives: To assess the effects of Sotagliflozin 200 mg and 400 mg versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight. To evaluate the safety of Sotagliflozin 200 mg and 400 mg versus placebo.

Detailed Description

The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

787 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Following a 2-week run-in period, participants received two placebo tablets (identical to sotagliflozin 200 mg in appearance), orally once daily, before the first meal of the day for up to 54 weeks.

Arm Title

Sotagliflozin 200 mg

Arm Type

Experimental

Arm Description

Arm Title

Sotagliflozin 400 mg

Arm Type

Experimental

Arm Description

Following a 2-week run-in period, participants received sotagliflozin 400 mg, administered as two 200 mg sotagliflozin tablets, orally once daily, before the first meal of the day for up to 60 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily. Route of administration: Oral

Intervention Type

Drug

Intervention Name(s)

Sotagliflozin

Other Intervention Name(s)

SAR439954

Intervention Description

Sotagliflozin 200 mg, tablet, orally once daily. Route of administration: Oral

Primary Outcome Measure Information:

Title

Change From Baseline in HbA1c at Week 26

Description

An Analysis of covariance (ANCOVA) model was used for analysis.

Time Frame

Baseline to Week 26

Secondary Outcome Measure Information:

Title

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Description

An ANCOVA model was used for analysis.

Time Frame

Baseline to Week 26

Title

Change From Baseline in SBP for Participants With Baseline SBP ≥130 mmHg at Week 12

Description

An ANCOVA model was used for analysis.

Time Frame

Baseline to Week 12

Title

Change From Baseline in SBP at Week 12 for All Participants

Description

An ANCOVA model was used for analysis.

Time Frame

Baseline to Week 12

Title

Change From Baseline in Body Weight at Week 26

Description

An ANCOVA model was used for analysis.

Time Frame

Baseline to Week 26

Title

Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)

Description

An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.

Time Frame

Baseline to Week 26

Title

Percentage of Participants With HbA1c <6.5% at Week 26

Time Frame

Week 26

Title

Percentage of Participants With HbA1c <7.0% at Week 26

Time Frame

Week 26

Title

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

Time Frame

Up to 60 weeks

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Hypoglycemic Events

Description

Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].

Time Frame

Up to 60 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria : Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an estimated glomerular filtration rate (eGFR) (based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation) of ≥30 and <60 milliliter per minute (mL/min)/1.73 meter square (m^2) (chronic kidney disease [CKD] 3A, 3B). Participants has given written informed consent to participate in the study in accordance with local regulations. Exclusion criteria: Hemoglobin A1c (HbA1c) of <7.0% or >11.0%. Type 1 diabetes. Women of childbearing potential (WOCBP) 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. Treatment with a sodium-glucose cotransporter type 2 (SGLT2) inhibitor (Canagliflozin, Dapagliflozin, Empagliflozin) during the last 12 months. Uncontrolled high blood pressure. Participants with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult. Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suman Wason, MD

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 8404018

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Investigational Site Number 8404045

City

Guntersville

State/Province

Alabama

ZIP/Postal Code

35976-2206

Country

United States

Facility Name

Investigational Site Number 8404004

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018-2701

Country

United States

Facility Name

Investigational Site Number 8404022

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050-7500

Country

United States

Facility Name

Investigational Site Number 8404007

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Investigational Site Number 8404023

City

Chula Vista

State/Province

California

ZIP/Postal Code

91910

Country

United States

Facility Name

Investigational Site Number 8404044

City

Gold River

State/Province

California

ZIP/Postal Code

95670

Country

United States

Facility Name

Investigational Site Number 8404011

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 8404003

City

Norco

State/Province

California

ZIP/Postal Code

92860

Country

United States

Facility Name

Investigational Site Number 8404025

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Investigational Site Number 8404038

City

San Dimas

State/Province

California

ZIP/Postal Code

91713

Country

United States

Facility Name

Investigational Site Number 8404019

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Investigational Site Number 8404001

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720-0834

Country

United States

Facility Name

Investigational Site Number 8404006

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761-4547

Country

United States

Facility Name

Investigational Site Number 8404064

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Investigational Site Number 8404043

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174-8187

Country

United States

Facility Name

Investigational Site Number 8404013

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157-5503

Country

United States

Facility Name

Investigational Site Number 8404016

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Investigational Site Number 8404040

City

Wauconda

State/Province

Illinois

ZIP/Postal Code

60084-2452

Country

United States

Facility Name

Investigational Site Number 8404036

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Investigational Site Number 8404020

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119-6302

Country

United States

Facility Name

Investigational Site Number 8404014

City

Norfolk

State/Province

Nebraska

ZIP/Postal Code

68701

Country

United States

Facility Name

Investigational Site Number 8404032

City

Papillion

State/Province

Nebraska

ZIP/Postal Code

68046-3136

Country

United States

Facility Name

Investigational Site Number 8404048

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601-1963

Country

United States

Facility Name

Investigational Site Number 8404009

City

Bronx

State/Province

New York

ZIP/Postal Code

10455

Country

United States

Facility Name

Investigational Site Number 8404074

City

New York

State/Province

New York

ZIP/Postal Code

00000

Country

United States

Facility Name

Investigational Site Number 8404051

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401-6638

Country

United States

Facility Name

Investigational Site Number 8404028

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103-3914

Country

United States

Facility Name

Investigational Site Number 8404029

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103-4027

Country

United States

Facility Name

Investigational Site Number 8404026

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45419-4336

Country

United States

Facility Name

Investigational Site Number 8404052

City

Lansdale

State/Province

Pennsylvania

ZIP/Postal Code

19446-1002

Country

United States

Facility Name

Investigational Site Number 8404031

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Investigational Site Number 8404021

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Investigational Site Number 8404056

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Investigational Site Number 8404015

City

Austin

State/Province

Texas

ZIP/Postal Code

78726-4061

Country

United States

Facility Name

Investigational Site Number 8404050

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Investigational Site Number 8404060

City

Austin

State/Province

Texas

ZIP/Postal Code

78749

Country

United States

Facility Name

Investigational Site Number 8404005

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702

Country

United States

Facility Name

Investigational Site Number 8404035

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208

Country

United States

Facility Name

Investigational Site Number 8404039

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Investigational Site Number 8404055

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Investigational Site Number 8404012

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

Facility Name

Investigational Site Number 8404033

City

Lampasas

State/Province

Texas

ZIP/Postal Code

76550-1820

Country

United States

Facility Name

Investigational Site Number 8404053

City

McAllen

State/Province

Texas

ZIP/Postal Code

78504

Country

United States

Facility Name

Investigational Site Number 8404057

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Investigational Site Number 8404059

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

Investigational Site Number 8404010

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78249-2782

Country

United States

Facility Name

Investigational Site Number 8404008

City

Layton

State/Province

Utah

ZIP/Postal Code

84041-1200

Country

United States

Facility Name

Investigational Site Number 8404042

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

Country

United States

Facility Name

Investigational Site Number 8404041

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Investigational Site Number 8404047

City

Kenosha

State/Province

Wisconsin

ZIP/Postal Code

53144

Country

United States

Facility Name

Investigational Site Number 0324001

City

Buenos Aires

ZIP/Postal Code

C1429BWN

Country

Argentina

Facility Name

Investigational Site Number 0324002

City

Caba

ZIP/Postal Code

1425DES

Country

Argentina

Facility Name

Investigational Site Number 0324005

City

Ciudad Autónoma Buenos Aires

ZIP/Postal Code

1205

Country

Argentina

Facility Name

Investigational Site Number 0324008

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Investigational Site Number 0324006

City

Córdoba

ZIP/Postal Code

X5008HHW

Country

Argentina

Facility Name

Investigational Site Number 0324009

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Investigational Site Number 0324007

City

Mar Del Plata

ZIP/Postal Code

B7600FYK

Country

Argentina

Facility Name

Investigational Site Number 0764007

City

Belo Horizonte

ZIP/Postal Code

30150-240

Country

Brazil

Facility Name

Investigational Site Number 0764001

City

Belém

ZIP/Postal Code

66073-005

Country

Brazil

Facility Name

Investigational Site Number 0764002

City

Curitiba

ZIP/Postal Code

80030-480

Country

Brazil

Facility Name

Investigational Site Number 0764008

City

Curitiba

ZIP/Postal Code

80810-040

Country

Brazil

Facility Name

Investigational Site Number 0764005

City

Rio De Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

Investigational Site Number 0764006

City

Sao Paulo

ZIP/Postal Code

04266-010

Country

Brazil

Facility Name

Investigational Site Number 0764004

City

São Paulo

ZIP/Postal Code

01244-030

Country

Brazil

Facility Name

Investigational Site Number 1244007

City

Brampton

ZIP/Postal Code

L6S 0C6

Country

Canada

Facility Name

Investigational Site Number 1244004

City

Burlington

ZIP/Postal Code

L7R 1A4

Country

Canada

Facility Name

Investigational Site Number 1244005

City

Etobicoke

ZIP/Postal Code

M9R 4E1

Country

Canada

Facility Name

Investigational Site Number 1244006

City

Laval

ZIP/Postal Code

H7T 2P5

Country

Canada

Facility Name

Investigational Site Number 1244009

City

Montreal

ZIP/Postal Code

H4A 2C6

Country

Canada

Facility Name

Investigational Site Number 1244010

City

Ottawa

ZIP/Postal Code

K2J 0V2

Country

Canada

Facility Name

Investigational Site Number 1244003

City

Thornhill

ZIP/Postal Code

L4J 8L7

Country

Canada

Facility Name

Investigational Site Number 1244002

City

Toronto

ZIP/Postal Code

M4C 5T2

Country

Canada

Facility Name

Investigational Site Number 1244008

City

Toronto

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

Investigational Site Number 1244001

City

Vancouver

ZIP/Postal Code

V5Y 3W2

Country

Canada

Facility Name

Investigational Site Number 1704008

City

Barranquilla

ZIP/Postal Code

080001

Country

Colombia

Facility Name

Investigational Site Number 1704007

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

Investigational Site Number 1704004

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Investigational Site Number 1704009

City

Bogota

ZIP/Postal Code

110911

Country

Colombia

Facility Name

Investigational Site Number 1704006

City

Ibague

ZIP/Postal Code

730006

Country

Colombia

Facility Name

Investigational Site Number 1704001

City

Manizales

ZIP/Postal Code

170004

Country

Colombia

Facility Name

Investigational Site Number 1704002

City

Medellin / Antioquia

ZIP/Postal Code

50021

Country

Colombia

Facility Name

Investigational Site Number 1704005

City

Zipaquira

ZIP/Postal Code

250252

Country

Colombia

Facility Name

Investigational Site Number 2764001

City

Frankfurt Am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Investigational Site Number 2764002

City

Hamburg

ZIP/Postal Code

21073

Country

Germany

Facility Name

Investigational Site Number 2764003

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Investigational Site Number 3484008

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Investigational Site Number 3484012

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Investigational Site Number 3484002

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Investigational Site Number 3484007

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Investigational Site Number 3484011

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

Investigational Site Number 3484005

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 3484001

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Investigational Site Number 3484010

City

Nyiregyhaza

ZIP/Postal Code

4405

Country

Hungary

Facility Name

Investigational Site Number 3484013

City

Nyregyhza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Investigational Site Number 3484004

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Investigational Site Number 3764001

City

Ashkelon

ZIP/Postal Code

7830604

Country

Israel

Facility Name

Investigational Site Number 3764010

City

Be'Er-Sheva

ZIP/Postal Code

84101

Country

Israel

Facility Name

Investigational Site Number 3764007

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Investigational Site Number 3764009

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Investigational Site Number 3764011

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Investigational Site Number 3764003

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

Investigational Site Number 3764004

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Investigational Site Number 3764006

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Investigational Site Number 3764005

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Investigational Site Number 3764002

City

Tel Aviv

ZIP/Postal Code

61480

Country

Israel

Facility Name

Investigational Site Number 3764008

City

Zefat

ZIP/Postal Code

13100

Country

Israel

Facility Name

Investigational Site Number 3764013

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Investigational Site Number 3804007

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Investigational Site Number 3804005

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Investigational Site Number 3804004

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigational Site Number 3804008

City

Naples

ZIP/Postal Code

80131

Country

Italy

Facility Name

Investigational Site Number 3804002

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Investigational Site Number 3804003

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Investigational Site Number 3804006

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Investigational Site Number 4844009

City

Chihuahua Chihuahua

ZIP/Postal Code

31217

Country

Mexico

Facility Name

Investigational Site Number 4844008

City

Durango, Durango

ZIP/Postal Code

34080

Country

Mexico

Facility Name

Investigational Site Number 4844001

City

Guadalajara

ZIP/Postal Code

44210

Country

Mexico

Facility Name

Investigational Site Number 4844003

City

Guadalajara

ZIP/Postal Code

44600

Country

Mexico

Facility Name

Investigational Site Number 4844006

City

Merida, Yucatan

ZIP/Postal Code

97130

Country

Mexico

Facility Name

Investigational Site Number 4844005

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Investigational Site Number 4844004

City

Xalapa

ZIP/Postal Code

91020

Country

Mexico

Facility Name

Investigational Site Number 6164002

City

Białystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Investigational Site Number 6164006

City

Katowice

ZIP/Postal Code

40-081

Country

Poland

Facility Name

Investigational Site Number 6164010

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Investigational Site Number 6164009

City

Krakow

ZIP/Postal Code

30-363

Country

Poland

Facility Name

Investigational Site Number 6164004

City

Krakow

ZIP/Postal Code

31-209

Country

Poland

Facility Name

Investigational Site Number 6164008

City

Krakow

ZIP/Postal Code

31-530

Country

Poland

Facility Name

Investigational Site Number 6164011

City

Lodz

ZIP/Postal Code

92-213

Country

Poland

Facility Name

Investigational Site Number 6164005

City

Oswiecim

ZIP/Postal Code

32-600

Country

Poland

Facility Name

Investigational Site Number 6164003

City

Rzeszow

ZIP/Postal Code

35-055

Country

Poland

Facility Name

Investigational Site Number 6164012

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Investigational Site Number 6164007

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Investigational Site Number 6424002

City

Bacau

ZIP/Postal Code

600154

Country

Romania

Facility Name

Investigational Site Number 6424001

City

Bacau

ZIP/Postal Code

600238

Country

Romania

Facility Name

Investigational Site Number 6424004

City

Bucuresti

ZIP/Postal Code

010825

Country

Romania

Facility Name

Investigational Site Number 6424009

City

Bucuresti

ZIP/Postal Code

013764

Country

Romania

Facility Name

Investigational Site Number 6424010

City

Bucuresti

ZIP/Postal Code

040172

Country

Romania

Facility Name

Investigational Site Number 6424006

City

Hunedoara

ZIP/Postal Code

331057

Country

Romania

Facility Name

Investigational Site Number 6424011

City

Oradea

ZIP/Postal Code

410159

Country

Romania

Facility Name

Investigational Site Number 6424003

City

Targu-Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Investigational Site Number 6434003

City

Chelyabinsk

ZIP/Postal Code

454047

Country

Russian Federation

Facility Name

Investigational Site Number 6434005

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

Investigational Site Number 6434002

City

Krasnodar

ZIP/Postal Code

3500

Country

Russian Federation

Facility Name

Investigational Site Number 6434004

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Investigational Site Number 6434001

City

St. Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Investigational Site Number 6434006

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Investigational Site Number 7104008

City

Cape Town

ZIP/Postal Code

7531

Country

South Africa

Facility Name

Investigational Site Number 7104002

City

Cape Town

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Investigational Site Number 7104001

City

Johannesburg

ZIP/Postal Code

1685

Country

South Africa

Facility Name

Investigational Site Number 7104010

City

Johannesburg

ZIP/Postal Code

2188

Country

South Africa

Facility Name

Investigational Site Number 7104005

City

Johannesburg

ZIP/Postal Code

2198

Country

South Africa

Facility Name

Investigational Site Number 7104006

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Investigational Site Number 7244011

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Investigational Site Number 7244007

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

Investigational Site Number 7244003

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Investigational Site Number 7244006

City

Palma De Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Investigational Site Number 7244001

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Investigational Site Number 7244002

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Investigational Site Number 7244009

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Investigational Site Number 8044004

City

Dnipropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Investigational Site Number 8044007

City

Kharkiv

ZIP/Postal Code

61106

Country

Ukraine

Facility Name

Investigational Site Number 8044010

City

Kharkiv

ZIP/Postal Code

61166

Country

Ukraine

Facility Name

Investigational Site Number 8044008

City

Kiev

ZIP/Postal Code

02002

Country

Ukraine

Facility Name

Investigational Site Number 8044003

City

Kiev

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Investigational Site Number 8044009

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Investigational Site Number 8044001

City

Kyiv

ZIP/Postal Code

03037

Country

Ukraine

Facility Name

Investigational Site Number 8044006

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Investigational Site Number 8044005

City

Lviv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Investigational Site Number 8044002

City

Zaporizhia

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control (SOTA-CKD3)

Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial