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

NCT ID: NCT03242252

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 787 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-16
• Study Completion Date: 2019-10-25

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.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease Stage 3

Study Design

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

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.

Route of administration: Oral

Sotagliflozin 200 mg

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.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.

Route of administration: Oral

Sotagliflozin

Intervention Type: DRUG

Sotagliflozin 200 mg, tablet, orally once daily.

Route of administration: Oral

Sotagliflozin 400 mg

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.

Group Type: EXPERIMENTAL

Sotagliflozin

Intervention Type: DRUG

Sotagliflozin 200 mg, tablet, orally once daily.

Route of administration: Oral

Interventions

Placebo

Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.

Route of administration: Oral

Intervention Type: DRUG

Sotagliflozin

Sotagliflozin 200 mg, tablet, orally once daily.

Route of administration: Oral

Intervention Type: DRUG

Other Intervention Names

SAR439954

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.

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

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Investigational Site Number 0324002

Caba, , Argentina

Investigational Site Number 8404018

Birmingham, Alabama, United States

Investigational Site Number 8404045

Guntersville, Alabama, United States

Investigational Site Number 8404004

Phoenix, Arizona, United States

Investigational Site Number 8404022

Phoenix, Arizona, United States

Investigational Site Number 8404007

Little Rock, Arkansas, United States

Investigational Site Number 8404023

Chula Vista, California, United States

Investigational Site Number 8404044

Gold River, California, United States

Investigational Site Number 8404011

Los Angeles, California, United States

Investigational Site Number 8404003

Norco, California, United States

Investigational Site Number 8404025

Northridge, California, United States

Investigational Site Number 8404038

San Dimas, California, United States

Investigational Site Number 8404019

Clearwater, Florida, United States

Investigational Site Number 8404001

DeLand, Florida, United States

Investigational Site Number 8404006

Ocoee, Florida, United States

Investigational Site Number 8404064

Orlando, Florida, United States

Investigational Site Number 8404043

Ormond Beach, Florida, United States

Investigational Site Number 8404013

Palmetto Bay, Florida, United States

Investigational Site Number 8404016

Savannah, Georgia, United States

Investigational Site Number 8404040

Wauconda, Illinois, United States

Investigational Site Number 8404036

Lake Charles, Louisiana, United States

Investigational Site Number 8404020

New Orleans, Louisiana, United States

Investigational Site Number 8404014

Norfolk, Nebraska, United States

Investigational Site Number 8404032

Papillion, Nebraska, United States

Investigational Site Number 8404048

Hackensack, New Jersey, United States

Investigational Site Number 8404074

New York, New York, United States

Investigational Site Number 8404009

The Bronx, New York, United States

Investigational Site Number 8404051

Wilmington, North Carolina, United States

Investigational Site Number 8404028

Winston-Salem, North Carolina, United States

Investigational Site Number 8404029

Winston-Salem, North Carolina, United States

Investigational Site Number 8404026

Dayton, Ohio, United States

Investigational Site Number 8404052

Lansdale, Pennsylvania, United States

Investigational Site Number 8404031

Anderson, South Carolina, United States

Investigational Site Number 8404021

Mt. Pleasant, South Carolina, United States

Investigational Site Number 8404056

Chattanooga, Tennessee, United States

Investigational Site Number 8404015

Austin, Texas, United States

Investigational Site Number 8404050

Austin, Texas, United States

Investigational Site Number 8404060

Austin, Texas, United States

Investigational Site Number 8404005

Beaumont, Texas, United States

Investigational Site Number 8404035

Dallas, Texas, United States

Investigational Site Number 8404039

Houston, Texas, United States

Investigational Site Number 8404055

Houston, Texas, United States

Investigational Site Number 8404012

Hurst, Texas, United States

Investigational Site Number 8404033

Lampasas, Texas, United States

Investigational Site Number 8404053

McAllen, Texas, United States

Investigational Site Number 8404057

Round Rock, Texas, United States

Investigational Site Number 8404059

San Antonio, Texas, United States

Investigational Site Number 8404010

San Antonio, Texas, United States

Investigational Site Number 8404008

Layton, Utah, United States

Investigational Site Number 8404042

Renton, Washington, United States

Investigational Site Number 8404041

Seattle, Washington, United States

Investigational Site Number 8404047

Kenosha, Wisconsin, United States

Investigational Site Number 0324001

Buenos Aires, , Argentina

Investigational Site Number 0324005

Ciudad Autónoma Buenos Aires, , Argentina

Investigational Site Number 0324008

Córdoba, , Argentina

Investigational Site Number 0324006

Córdoba, , Argentina

Investigational Site Number 0324009

La Plata, , Argentina

Investigational Site Number 0324007

Mar del Plata, , Argentina

Investigational Site Number 0764001

Belém, , Brazil

Investigational Site Number 0764007

Belo Horizonte, , Brazil

Investigational Site Number 0764002

Curitiba, , Brazil

Investigational Site Number 0764008

Curitiba, , Brazil

Investigational Site Number 0764005

Rio de Janeiro, , Brazil

Investigational Site Number 0764004

São Paulo, , Brazil

Investigational Site Number 0764006

São Paulo, , Brazil

Investigational Site Number 1244007

Brampton, , Canada

Investigational Site Number 1244004

Burlington, , Canada

Investigational Site Number 1244005

Etobicoke, , Canada

Investigational Site Number 1244006

Laval, , Canada

Investigational Site Number 1244009

Montreal, , Canada

Investigational Site Number 1244010

Ottawa, , Canada

Investigational Site Number 1244003

Thornhill, , Canada

Investigational Site Number 1244002

Toronto, , Canada

Investigational Site Number 1244008

Toronto, , Canada

Investigational Site Number 1244001

Vancouver, , Canada

Investigational Site Number 1704008

Barranquilla, , Colombia

Investigational Site Number 1704007

Barranquilla, , Colombia

Investigational Site Number 1704004

Bogotá, , Colombia

Investigational Site Number 1704009

Bogotá, , Colombia

Investigational Site Number 1704006

Ibagué, , Colombia

Investigational Site Number 1704001

Manizales, , Colombia

Investigational Site Number 1704002

Medellin / Antioquia, , Colombia

Investigational Site Number 1704005

Zipaquirá, , Colombia

Investigational Site Number 2764001

Frankfurt am Main, , Germany

Investigational Site Number 2764002

Hamburg, , Germany

Investigational Site Number 2764003

Münster, , Germany

Investigational Site Number 3484008

Baja, , Hungary

Investigational Site Number 3484012

Baja, , Hungary

Investigational Site Number 3484002

Balatonfüred, , Hungary

Investigational Site Number 3484007

Budapest, , Hungary

Investigational Site Number 3484011

Debrecen, , Hungary

Investigational Site Number 3484005

Debrecen, , Hungary

Investigational Site Number 3484001

Gyula, , Hungary

Investigational Site Number 3484010

Nyíregyháza, , Hungary

Investigational Site Number 3484013

Nyregyhza, , Hungary

Investigational Site Number 3484004

Pécs, , Hungary

Investigational Site Number 3764001

Ashkelon, , Israel

Investigational Site Number 3764010

Beersheba, , Israel

Investigational Site Number 3764007

Haifa, , Israel

Investigational Site Number 3764009

Kfar Saba, , Israel

Investigational Site Number 3764011

Kfar Saba, , Israel

Investigational Site Number 3764003

Nahariya, , Israel

Investigational Site Number 3764004

Petah Tikva, , Israel

Investigational Site Number 3764006

Ramat Gan, , Israel

Investigational Site Number 3764005

Rehovot, , Israel

Investigational Site Number 3764008

Safed, , Israel

Investigational Site Number 3764002

Tel Aviv, , Israel

Investigational Site Number 3764013

Ẕerifin, , Israel

Investigational Site Number 3804007

Catania, , Italy

Investigational Site Number 3804005

Milan, , Italy

Investigational Site Number 3804004

Milan, , Italy

Investigational Site Number 3804008

Naples, , Italy

Investigational Site Number 3804002

Napoli, , Italy

Investigational Site Number 3804003

Roma, , Italy

Investigational Site Number 3804006

Siena, , Italy

Investigational Site Number 4844009

Chihuahua Chihuahua, , Mexico

Investigational Site Number 4844008

Durango, Durango, , Mexico

Investigational Site Number 4844001

Guadalajara, , Mexico

Investigational Site Number 4844003

Guadalajara, , Mexico

Investigational Site Number 4844006

Merida, Yucatan, , Mexico

Investigational Site Number 4844005

Monterrey, , Mexico

Investigational Site Number 4844004

Xalapa, , Mexico

Investigational Site Number 6164002

Bialystok, , Poland

Investigational Site Number 6164006

Katowice, , Poland

Investigational Site Number 6164010

Krakow, , Poland

Investigational Site Number 6164009

Krakow, , Poland

Investigational Site Number 6164004

Krakow, , Poland

Investigational Site Number 6164008

Krakow, , Poland

Investigational Site Number 6164011

Lodz, , Poland

Investigational Site Number 6164005

Oświęcim, , Poland

Investigational Site Number 6164003

Rzeszów, , Poland

Investigational Site Number 6164012

Skierniewice, , Poland

Investigational Site Number 6164007

Warsaw, , Poland

Investigational Site Number 6424002

Bacau, , Romania

Investigational Site Number 6424001

Bacau, , Romania

Investigational Site Number 6424004

Bucharest, , Romania

Investigational Site Number 6424009

Bucharest, , Romania

Investigational Site Number 6424010

Bucharest, , Romania

Investigational Site Number 6424006

Hunedoara, , Romania

Investigational Site Number 6424011

Oradea, , Romania

Investigational Site Number 6424003

Târgu Mureş, , Romania

Investigational Site Number 6434003

Chelyabinsk, , Russia

Investigational Site Number 6434005

Kemerovo, , Russia

Investigational Site Number 6434002

Krasnodar, , Russia

Investigational Site Number 6434004

Novosibirsk, , Russia

Investigational Site Number 6434001

Saint Petersburg, , Russia

Investigational Site Number 6434006

Yaroslavl, , Russia

Investigational Site Number 7104008

Cape Town, , South Africa

Investigational Site Number 7104002

Cape Town, , South Africa

Investigational Site Number 7104001

Johannesburg, , South Africa

Investigational Site Number 7104010

Johannesburg, , South Africa

Investigational Site Number 7104005

Johannesburg, , South Africa

Investigational Site Number 7104006

Pretoria, , South Africa

Investigational Site Number 7244011

Barcelona, , Spain

Investigational Site Number 7244007

Granada, , Spain

Investigational Site Number 7244003

Madrid, , Spain

Investigational Site Number 7244006

Palma de Mallorca, , Spain

Investigational Site Number 7244001

Seville, , Spain

Investigational Site Number 7244002

Valencia, , Spain

Investigational Site Number 7244009

Zaragoza, , Spain

Investigational Site Number 8044004

Dnipropetrovsk, , Ukraine

Investigational Site Number 8044007

Kharkiv, , Ukraine

Investigational Site Number 8044010

Kharkiv, , Ukraine

Investigational Site Number 8044008

Kiev, , Ukraine

Investigational Site Number 8044003

Kiev, , Ukraine

Investigational Site Number 8044009

Kyiv, , Ukraine

Investigational Site Number 8044001

Kyiv, , Ukraine

Investigational Site Number 8044006

Kyiv, , Ukraine

Investigational Site Number 8044005

Lviv, , Ukraine

Investigational Site Number 8044002

Zaporizhia, , Ukraine

Countries

United States; Argentina; Brazil; Canada; Colombia; Germany; Hungary; Israel; Italy; Mexico; Poland; Romania; Russia; South Africa; Spain; Ukraine

References

Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Powell DR, Davies MJ, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. Diabetes Obes Metab. 2023 Jun;25(6):1646-1657. doi: 10.1111/dom.15019. Epub 2023 Feb 28.

Reference Type: DERIVED

PMID: 36782093 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-004889-26

Identifier Type: -

Identifier Source: secondary_id

U1111-1187-8662

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14837

Identifier Type: -

Identifier Source: org_study_id