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NCT03351478 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

— SOTA-EMPA  

Official title:
A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03351478
Other study ID # EFC14867
Secondary ID 2016-001803-22U1
Status Completed
Phase Phase 3
First received
Last updated
Start date November 27, 2017
Est. completion date May 16, 2019

Study information
Verified date April 2021
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.

Recruitment information / eligibility
Status Completed
Enrollment 770
Est. completion date May 16, 2019
Est. primary completion date May 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria : - Participants with Type 2 Diabetes on Dipeptidyl peptidase-4 inhibitors(DPP4(i)) with or without metformin at a stable dose for at least 12 weeks prior to Screening Visit. Metformin dose will be =1500 mg per day (or maximum tolerated dose [documented]). DPP4(i) dose must be the appropriate dose as per local label. - Signed written informed consent. Exclusion criteria: - Body mass index (BMI) =20 kg/m^2 or >45 kg/m^2 at Screening. - Use of any antidiabetic drug other than DPP4 inhibitors and metformin within 12 weeks preceding the Screening Visit. - Participants who have previously participated in any clinical trial of sotagliflozin/LX4211. - Use of a selective sodium-glucose co-transporter type 2 (SGLT2) inhibitor (e.g., canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the screening visit. - Participants with severe anemia, severe cardiovascular disease (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or participants with a short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make the implementation of the protocol or interpretation of the study results difficult. - Current diagnosis of chronic hepatitis and/or other clinically active liver disease requiring treatment. - Participants with contraindication to empagliflozin as per local labelling. - Participants with contraindication to metformin as per local labelling. - Hemoglobin A1c <7.0% or >11.0% at Screening (central laboratory). - Fasting plasma glucose >270 mg/dL (>15.0 mmol/L) measured by the central laboratory at Screening (Visit 1), and confirmed by a repeat test (>270 mg/dL [>15.0 mmol/L]) before Randomization. - Previous use of any type of insulin for >1 month (except for treatment of gestational diabetes). - Pregnant (confirmed by serum pregnancy test at Screening) or breast-feeding women. - Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and follow-up period, or who are unwilling or unable to be tested for pregnancy during the study. - Mean of 3 separate blood pressure (BP) measurements >180 mmHg (systolic blood pressure [SBP]) or >100 mmHg (diastolic blood pressure [DBP]). - History of the hypertensive crisis resulting in emergency medical care within 12 weeks prior to Screening Visit. - Lower extremity complications (such as skin ulcers, infection, osteomyelitis, and gangrene) identified during the Screening period, and still requiring treatment at Randomization. - Laboratory findings with the central laboratory tests at Visit 1: - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range (ULN); - Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome); - Neutrophils <1 500/mm^3 (or according to ethnic group) and/or platelets <100 000/mm^3; - Amylase and/or lipase >3 times the ULN; - Participants with renal impairment as defined by the estimated glomerular filtration rate (eGFR) criterion that precludes initiation of empagliflozin as per the approved local label (eg, <45 mL/min/1.73 m^2 in US; <60 mL/min/1.73 m^2 in EU). - Secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome). - If the participant is on hypertensive medications, the antihypertensive has been changed in the 8 weeks prior to Screening (new drug or new dose). The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sotagliflozin
Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.
• Empagliflozin
Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.
• Placebo
Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.
• Placebo
Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.

Locations
Country Name City State
Bulgaria Investigational Site Number 1008011 Gabrovo
Bulgaria Investigational Site Number 1008001 Plovdiv
Bulgaria Investigational Site Number 1008006 Plovdiv
Bulgaria Investigational Site Number 1008005 Ruse
Bulgaria Investigational Site Number 1008007 Ruse
Bulgaria Investigational Site Number 1008002 Smolyan
Bulgaria Investigational Site Number 1008008 Sofia
Bulgaria Investigational Site Number 1008012 Sofia
Bulgaria Investigational Site Number 1008003 Stara Zagora
Bulgaria Investigational Site Number 1008010 Stara Zagora
Bulgaria Investigational Site Number 1008004 Varna
Canada Investigational Site Number 1248001 Brampton
Canada Investigational Site Number 1248007 Burlington
Canada Investigational Site Number 1248003 Newmarket
Canada Investigational Site Number 1248010 Quebec
Canada Investigational Site Number 1248009 Sherbrooke
Canada Investigational Site Number 1248002 Thornhill
Canada Investigational Site Number 1248004 Toronto
Canada Investigational Site Number 1248011 Toronto
Canada Investigational Site Number 1248005 Vancouver
Canada Investigational Site Number 1248008 Victoriaville
Czechia Investigational Site Number 2038007 Brandys
Czechia Investigational Site Number 2038003 Havirov
Czechia Investigational Site Number 2038004 Krnov
Czechia Investigational Site Number 2038011 Ostrava
Czechia Investigational Site Number 2038006 Pardubice
Czechia Investigational Site Number 2038010 Plzen
Czechia Investigational Site Number 2038005 Prague
Czechia Investigational Site Number 2038009 Praha 1
Czechia Investigational Site Number 2038001 Praha 10 - Uhrineves
Czechia Investigational Site Number 2038013 Praha 2
Czechia Investigational Site Number 2038002 Praha 4
Czechia Investigational Site Number 2038008 Praha 9
France Investigational Site Number 2508005 Corbeil-Essonnes
France Investigational Site Number 2508006 La Roche Sur Yon
France Investigational Site Number 2508007 La Tronche
France Investigational Site Number 2508003 Mulhouse
France Investigational Site Number 2508002 Nantes Cedex 1
France Investigational Site Number 2508001 Paris
France Investigational Site Number 2508004 Saint-Mandé
Italy Investigational Site Number 3808003 Catania
Italy Investigational Site Number 3808010 Catania
Italy Investigational Site Number 3808002 Chieti
Italy Investigational Site Number 3808004 Milano
Italy Investigational Site Number 3808005 Milano
Italy Investigational Site Number 3808009 Pavia
Italy Investigational Site Number 3808001 Roma
Italy Investigational Site Number 3808007 Roma
Italy Investigational Site Number 3808008 Roma
Italy Investigational Site Number 3808011 San Giovanni Rotondo
Italy Investigational Site Number 3808006 Siena
Latvia Investigational Site Number 4288004 Kuldiga
Latvia Investigational Site Number 4288008 Limbazi
Latvia Investigational Site Number 4288003 Ogre
Latvia Investigational Site Number 4288001 Riga
Latvia Investigational Site Number 4288002 Riga
Latvia Investigational Site Number 4288007 Riga
Latvia Investigational Site Number 4288006 Sigulda
Latvia Investigational Site Number 4288005 Talsi
Mexico Investigational Site Number 4848002 Chihuahua
Mexico Investigational Site Number 4848003 Cuernavaca
Mexico Investigational Site Number 4848007 Durango, Durango
Mexico Investigational Site Number 4848011 Mexico City
Mexico Investigational Site Number 4848001 Monterrey
Mexico Investigational Site Number 4848005 Monterrey
Mexico Investigational Site Number 4848012 Monterrey
Russian Federation Investigational Site Number 6438008 Chelyabinsk
Russian Federation Investigational Site Number 6438006 Dzerzhinsky
Russian Federation Investigational Site Number 6438009 Kemerovo
Russian Federation Investigational Site Number 6438010 Novosibirsk
Russian Federation Investigational Site Number 6438001 Saint-Petersburg
Russian Federation Investigational Site Number 6438002 Saint-Petersburg
Russian Federation Investigational Site Number 6438003 Saint-Petersburg
Russian Federation Investigational Site Number 6438005 Saint-Petersburg
Russian Federation Investigational Site Number 6438013 Saint-Petersburg
Russian Federation Investigational Site Number 6438012 Saratov
Russian Federation Investigational Site Number 6438014 St. Petersburg
Russian Federation Investigational Site Number 6438015 Volgograd
Russian Federation Investigational Site Number 6438007 Vsevolozhsk
Russian Federation Investigational Site Number 6438011 Yaroslavl
Slovakia Investigational Site Number 7038005 Bardejov
Slovakia Investigational Site Number 7038009 Bratislava
Slovakia Investigational Site Number 7038001 Kosice
Slovakia Investigational Site Number 7038006 Lucenec
Slovakia Investigational Site Number 7038008 Nove Zamky
Slovakia Investigational Site Number 7038004 Povazska Bystrica
Slovakia Investigational Site Number 7038002 Roznava
Slovakia Investigational Site Number 7038007 Sabinov
Slovakia Investigational Site Number 7038003 Vrutky
Spain Investigational Site Number 7248006 Barcelona
Spain Investigational Site Number 7248002 Córdoba
Spain Investigational Site Number 7248005 Malaga Malaga
Spain Investigational Site Number 7248010 Santa Coloma De Gramenet
Spain Investigational Site Number 7248009 Santiago De Compostela
Spain Investigational Site Number 7248001 Sevilla
Spain Investigational Site Number 7248004 Sevilla
Spain Investigational Site Number 7248008 Sevilla
Spain Investigational Site Number 7248003 Valencia Valencia
Spain Investigational Site Number 7248007 Zaragoza
United Kingdom Investigational Site Number 8268008 Darlington
United Kingdom Investigational Site Number 8268004 Dundee
United Kingdom Investigational Site Number 8268006 Exeter
United Kingdom Investigational Site Number 8268001 Hull
United Kingdom Investigational Site Number 8268002 Huntingdon
United Kingdom Investigational Site Number 8268007 Sheffield
United Kingdom Investigational Site Number 8268003 Southampton
United Kingdom Investigational Site Number 8268005 Wolverhampton
United States Investigational Site Number 8408035 Birmingham Alabama
United States Investigational Site Number 8408051 Blackfoot Idaho
United States Investigational Site Number 8408007 Bountiful Utah
United States Investigational Site Number 8408072 Brownsville Texas
United States Investigational Site Number 8408006 Burke Virginia
United States Investigational Site Number 8408061 Columbus Georgia
United States Investigational Site Number 8408052 Dallas Texas
United States Investigational Site Number 8408056 Dallas Texas
United States Investigational Site Number 8408082 Dallas Texas
United States Investigational Site Number 8408033 Elgin Illinois
United States Investigational Site Number 8408044 Fall River Massachusetts
United States Investigational Site Number 8408037 Fayetteville North Carolina
United States Investigational Site Number 8408008 Flint Michigan
United States Investigational Site Number 8408060 Fort Mill South Carolina
United States Investigational Site Number 8408012 Greensboro North Carolina
United States Investigational Site Number 8408053 Greensboro North Carolina
United States Investigational Site Number 8408047 Hawaiian Gardens California
United States Investigational Site Number 8408026 Holladay Utah
United States Investigational Site Number 8408001 Houston Texas
United States Investigational Site Number 8408016 Houston Texas
United States Investigational Site Number 8408017 Houston Texas
United States Investigational Site Number 8408022 Houston Texas
United States Investigational Site Number 8408032 Houston Texas
United States Investigational Site Number 8408036 Houston Texas
United States Investigational Site Number 8408018 Jefferson City Tennessee
United States Investigational Site Number 8408029 Katy Texas
United States Investigational Site Number 8408010 Knoxville Tennessee
United States Investigational Site Number 8408038 Knoxville Tennessee
United States Investigational Site Number 8408074 Macon Georgia
United States Investigational Site Number 8408004 Manassas Virginia
United States Investigational Site Number 8408054 McAllen Texas
United States Investigational Site Number 8408039 Mesquite Texas
United States Investigational Site Number 8408009 Miami Florida
United States Investigational Site Number 8408003 New Orleans Louisiana
United States Investigational Site Number 8408069 Northglenn Colorado
United States Investigational Site Number 8408049 Ocoee Florida
United States Investigational Site Number 8408045 Oklahoma City Oklahoma
United States Investigational Site Number 8408005 Orlando Florida
United States Investigational Site Number 8408040 Orlando Florida
United States Investigational Site Number 8408019 Palmetto Bay Florida
United States Investigational Site Number 8408042 Plano Texas
United States Investigational Site Number 8408064 Port Charlotte Florida
United States Investigational Site Number 8408002 Rockville Maryland
United States Investigational Site Number 8408013 Salisbury North Carolina
United States Investigational Site Number 8408011 San Antonio Texas
United States Investigational Site Number 8408079 Savannah Georgia
United States Investigational Site Number 8408041 Schertz Texas
United States Investigational Site Number 8408028 Sheffield Alabama
United States Investigational Site Number 8408031 Spring Valley California
United States Investigational Site Number 8408059 Statesboro Georgia
United States Investigational Site Number 8408067 Van Nuys California
United States Investigational Site Number 8408068 Warwick Rhode Island
United States Investigational Site Number 8408027 West Seneca New York

Sponsors (2)
Lead Sponsor Collaborator
Lexicon Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  France,  Italy,  Latvia,  Mexico,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26 An analysis of covariance (ANCOVA) model was used for the analysis. Baseline, Week 26
Secondary Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP = 130 mmHg An ANCOVA model was used for the analysis. Baseline, Week 12
Secondary Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26 An ANCOVA model was used for the analysis. Baseline, Week 26
Secondary Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 An ANCOVA model was used for the analysis. Baseline, Week 26
Secondary Change From Baseline in Body Weight at Week 26 An ANCOVA model was used for the analysis. Baseline, Week 26
Secondary Change From Baseline in Sitting SBP at Week 12 for All Participants An ANCOVA model was used for the analysis. Baseline, Week 12
Secondary Percentage of Participants With HbA1c <6.5% at Week 26 Week 26
Secondary Percentage of Participants With HbA1c <7.0% at Week 26 Week 26
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