Last updated on March 2019

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin


Brief description of study

Primary Objective:

To demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes (T2D) who have inadequate glycemic control on a Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) with or without metformin.

Secondary Objectives:

  • To demonstrate non-inferiority of sotagliflozin versus empagliflozin on HbA1c reduction.
  • To demonstrate the superiority of sotagliflozin versus placebo on 2-hour postprandial glucose (PPG) reduction, fasting plasma glucose (FPG) reduction, body weight reduction, on the proportion of patients with HbA1c <6.5% and <7.0%, and on sitting systolic blood pressure (SBP) reduction.
  • To demonstrate the superiority of sotagliflozin versus empagliflozin on HbA1c reduction and sitting SBP reduction.
  • To evaluate the safety of sotagliflozin versus empagliflozin, and placebo, throughout the trial.

Detailed Study Description

Up to 34 weeks, including a Screening Phase of up to 2 weeks, a 2 week Run-In Phase, a 26-week double-blind Treatment Period and a 4-week post-treatment Follow-up Period to collect safety information.

Clinical Study Identifier: NCT03351478

Contact Investigators or Research Sites near you

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Investigational Site Number 8408035

Birmingham, AL United States

Investigational Site Number 8408028

Sheffield, AL United States

Investigational Site Number 8408047

Hawaiian Gardens, CA United States

Investigational Site Number 8408031

Spring Valley, CA United States

Investigational Site Number 8408009

Miami, FL United States

Investigational Site Number 8408049

Ocoee, FL United States

Investigational Site Number 8408040

Orlando, FL United States

Investigational Site Number 8408019

Palmetto Bay, FL United States

Investigational Site Number 8408074

Macon, GA United States

Investigational Site Number 8408059

Statesboro, GA United States

Investigational Site Number 8408051

Blackfoot, ID United States

Investigational Site Number 8408033

Elgin, IL United States

Investigational Site Number 8408003

New Orleans, LA United States

Investigational Site Number 8408002

Rockville, MD United States

Investigational Site Number 8408044

Fall River, MA United States

Investigational Site Number 8408008

Flint, MI United States

Investigational Site Number 8408027

West Seneca, NY United States

Investigational Site Number 8408037

Fayetteville, NC United States

Investigational Site Number 8408053

Greensboro, NC United States

Investigational Site Number 8408012

Greensboro, NC United States

Investigational Site Number 8408073

Erie, PA United States

Investigational Site Number 8408060

Fort Mill, SC United States

Investigational Site Number 8408082

Dallas, TX United States

Investigational Site Number 8408001

Houston, TX United States

Investigational Site Number 8408016

Houston, TX United States

Investigational Site Number 8408017

Houston, TX United States

Investigational Site Number 8408022

Houston, TX United States

Investigational Site Number 8408036

Houston, TX United States

Investigational Site Number 8408029

Katy, TX United States

Investigational Site Number 8408054

McAllen, TX United States

Investigational Site Number 8408039

Mesquite, TX United States

Investigational Site Number 8408042

Plano, TX United States

Investigational Site Number 8408011

San Antonio, TX United States

Investigational Site Number 8408041

Schertz, TX United States

Investigational Site Number 8408026

Holladay, UT United States

Investigational Site Number 8408006

Burke, VA United States

Investigational Site Number 8408004

Manassas, VA United States

Investigational Site Number 8408005

Orlando, FL United States

Investigational Site Number 8408024

Lawrenceville, GA United States

Investigational Site Number 8408062

Media, PA United States

Investigational Site Number 8408056

Dallas, TX United States

Investigational Site Number 8408032

Houston, TX United States

Investigational Site Number 8408007

Bountiful, UT United States

Investigational Site Number 1248008

Victoriaville, Canada

Investigational Site Number 8408043

Escondido, CA United States

Investigational Site Number 8408069

Northglenn, CO United States

Investigational Site Number 8408061

Columbus, GA United States

Investigational Site Number 8408018

Jefferson City, TN United States

Investigational Site Number 1008003

Stara Zagora, Bulgaria

Investigational Site Number 1008010

Stara Zagora, Bulgaria

Investigational Site Number 8408013

Salisbury, NC United States

Investigational Site Number 8408010

Knoxville, TN United States

Investigational Site Number 8408038

Knoxville, TN United States

Investigational Site Number 2508002

Nantes Cedex 1, France

Investigational Site Number 7038004

Povazska Bystrica, Slovakia

Investigational Site Number 8408050

Birmingham, AL United States

Investigational Site Number 8408030

San Dimas, CA United States

Investigational Site Number 8408077

Seymour, TN United States

Investigational Site Number 2508005

Corbeil-Essonnes, France

Investigational Site Number 8268008

Darlington, United Kingdom

Investigational Site Number 8408063

Cromwell, CT United States

Investigational Site Number 8408025

New York, NY United States

Investigational Site Number 2508006

La roche sur yon, France

Investigational Site Number 3808011

San Giovanni Rotondo, Italy

Investigational Site Number 6438008

Chelyabinsk, Russian Federation

Investigational Site Number 6438009

Kemerovo, Russian Federation

Investigational Site Number 6438002

Saint-Petersburg, Russian Federation

Investigational Site Number 6438001

Saint-Petersburg, Russian Federation

Investigational Site Number 8268004

Dundee, United Kingdom

Investigational Site Number 8268006

Exeter, United Kingdom

Investigational Site Number 8268002

Huntingdon, United Kingdom

Investigational Site Number 8408067

Van Nuys, CA United States

Investigational Site Number 8408079

Savannah, GA United States

Investigational Site Number 8408052

Dallas, TX United States

Investigational Site Number 2508006

La Roche Sur Yon, France

Investigational Site Number 6438006

Dzerzhinsky, Russian Federation

Investigational Site Number 6438010

Novosibirsk, Russian Federation

Investigational Site Number 6438013

Saint-Petersburg, Russian Federation

Investigational Site Number 6438005

Saint-Petersburg, Russian Federation

Investigational Site Number 6438014

St. Petersburg, Russian Federation

Investigational Site Number 6438007

Vsevolozhsk, Russian Federation

Investigational Site Number 6438011

Yaroslavl, Russian Federation

Investigational Site Number 7248010

Santa Coloma De Gramenet, Spain

Investigational Site Number 8268007

Sheffield, United Kingdom

Investigational Site Number 8268003

Southampton, United Kingdom

Investigational Site Number 8408081

Oviedo, FL United States

Investigational Site Number 8408064

Port Charlotte, FL United States

Investigational Site Number 8408078

Tampa, FL United States

Investigational Site Number 8408045

Oklahoma City, OK United States

Investigational Site Number 8408071

Greensburg, PA United States

Investigational Site Number 8408021

Charleston, SC United States

Investigational Site Number 8408072

Brownsville, TX United States

Investigational Site Number 8408058

Houston, TX United States

Investigational Site Number 6438003

Saint-Petersburg, Russian Federation

Investigational Site Number 6438012

Saratov, Russian Federation

Investigational Site Number 6438015

Volgograd, Russian Federation

Investigational Site Number 7248003

Valencia Valencia, Spain

Investigational Site Number 8268005

Wolverhampton, United Kingdom

Investigational Site Number 8408068

Warwick, RI United States

Investigational Site Number 4848007

Durango, Durango, Mexico

Investigational Site Number 7248009

Santiago De Compostela, Spain

Recruitment Status: Closed


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