AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3SOTA-EMPANCT03351478

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

A Phase 3 study testing Sotagliflozin and Empagliflozin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 160 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Sotagliflozin and Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
770 participants
Where
160 sitesin 12 countries
Study dates
27 Nov 2017to 16 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

160 sites in 12 countries.

160 sites in 12 countries

United States53 sites

  • Investigational Site Number 8408035

    Birmingham, Alabama, 35205

  • Investigational Site Number 8408051

    Blackfoot, Idaho, 83221

  • Investigational Site Number 8408007

    Bountiful, Utah, 84010-7717

  • Investigational Site Number 8408072

    Brownsville, Texas, 78520-7512

  • Investigational Site Number 8408006

    Burke, Virginia, 22015

  • Investigational Site Number 8408061

    Columbus, Georgia, 31904

  • Investigational Site Number 8408056

    Dallas, Texas, 75208

  • Investigational Site Number 8408082

    Dallas, Texas, 75230

  • Investigational Site Number 8408052

    Dallas, Texas, 75231

  • Investigational Site Number 8408033

    Elgin, Illinois, 60124

  • Investigational Site Number 8408044

    Fall River, Massachusetts, 02721-3005

  • Investigational Site Number 8408037

    Fayetteville, North Carolina, 28314

  • Investigational Site Number 8408008

    Flint, Michigan, 48532

  • Investigational Site Number 8408060

    Fort Mill, South Carolina, 29707-4514

  • Investigational Site Number 8408053

    Greensboro, North Carolina, 27408-7042

  • Investigational Site Number 8408012

    Greensboro, North Carolina, 27408

  • Investigational Site Number 8408047

    Hawaiian Gardens, California, 90716

  • Investigational Site Number 8408026

    Holladay, Utah, 84117

  • Investigational Site Number 8408001

    Houston, Texas, 77004

  • Investigational Site Number 8408032

    Houston, Texas, 77004

  • Investigational Site Number 8408016

    Houston, Texas, 77040

  • Investigational Site Number 8408017

    Houston, Texas, 77058

  • Investigational Site Number 8408036

    Houston, Texas, 77061

  • Investigational Site Number 8408022

    Houston, Texas, 77099

  • Investigational Site Number 8408018

    Jefferson City, Tennessee, 37760

  • Investigational Site Number 8408029

    Katy, Texas, 77450

  • Investigational Site Number 8408010

    Knoxville, Tennessee, 37912-4707

  • Investigational Site Number 8408038

    Knoxville, Tennessee, 37938

  • Investigational Site Number 8408074

    Macon, Georgia, 31210

  • Investigational Site Number 8408004

    Manassas, Virginia, 20110

  • Investigational Site Number 8408054

    McAllen, Texas, 78504

  • Investigational Site Number 8408039

    Mesquite, Texas, 75149

  • Investigational Site Number 8408009

    Miami, Florida, 33183-4825

  • Investigational Site Number 8408003

    New Orleans, Louisiana, 70124

  • Investigational Site Number 8408069

    Northglenn, Colorado, 80234

  • Investigational Site Number 8408049

    Ocoee, Florida, 34761

  • Investigational Site Number 8408045

    Oklahoma City, Oklahoma, 73104-3252

  • Investigational Site Number 8408005

    Orlando, Florida, 32810

  • Investigational Site Number 8408040

    Orlando, Florida, 32825

  • Investigational Site Number 8408019

    Palmetto Bay, Florida, 33157-5503

  • Investigational Site Number 8408042

    Plano, Texas, 75024

  • Investigational Site Number 8408064

    Port Charlotte, Florida, 33952

  • Investigational Site Number 8408002

    Rockville, Maryland, 20852

  • Investigational Site Number 8408013

    Salisbury, North Carolina, 28144-2742

  • Investigational Site Number 8408011

    San Antonio, Texas, 78229-3818

  • Investigational Site Number 8408079

    Savannah, Georgia, 31406

  • Investigational Site Number 8408041

    Schertz, Texas, 78154

  • Investigational Site Number 8408028

    Sheffield, Alabama, 35660

  • Investigational Site Number 8408031

    Spring Valley, California, 91978

  • Investigational Site Number 8408059

    Statesboro, Georgia, 30461-0845

  • Investigational Site Number 8408067

    Van Nuys, California, 91405

  • Investigational Site Number 8408068

    Warwick, Rhode Island, 02888-3360

  • Investigational Site Number 8408027

    West Seneca, New York, 14224

Other trials in United States

Russia14 sites

  • Investigational Site Number 6438008

    Chelyabinsk, 454047

  • Investigational Site Number 6438006

    Dzerzhinsky, 140091

  • Investigational Site Number 6438009

    Kemerovo, 650002

  • Investigational Site Number 6438010

    Novosibirsk, 630091

  • Investigational Site Number 6438013

    Saint Petersburg, 190013

  • Investigational Site Number 6438003

    Saint Petersburg, 192012

  • Investigational Site Number 6438014

    Saint Petersburg, 194354

  • Investigational Site Number 6438002

    Saint Petersburg, 194358

  • Investigational Site Number 6438005

    Saint Petersburg, 195213

  • Investigational Site Number 6438001

    Saint Petersburg, 196601

  • Investigational Site Number 6438012

    Saratov, 410054

  • Investigational Site Number 6438015

    Volgograd, 400001

  • Investigational Site Number 6438007

    Vsevolozhsk, 188643

  • Investigational Site Number 6438011

    Yaroslavl, 150002

Other trials in Russia

Czechia12 sites

  • Investigational Site Number 2038007

    Brandys, 250 01

  • Investigational Site Number 2038003

    Havířov, 736 01

  • Investigational Site Number 2038004

    Krnov, 794 01

  • Investigational Site Number 2038011

    Ostrava, 710 00

  • Investigational Site Number 2038006

    Pardubice, 530 02

  • Investigational Site Number 2038010

    Pilsen, 363 01

  • Investigational Site Number 2038009

    Prague, 110 00

  • Investigational Site Number 2038013

    Prague, 128 00

  • Investigational Site Number 2038002

    Prague, 149 00

  • Investigational Site Number 2038005

    Prague, 18100

  • Investigational Site Number 2038008

    Prague, 190 14

  • Investigational Site Number 2038001

    Praha 10 - Uhrineves, 104 00

Other trials in Czechia

Bulgaria11 sites

  • Investigational Site Number 1008011

    Gabrovo, 5300

  • Investigational Site Number 1008006

    Plovdiv, 4000

  • Investigational Site Number 1008001

    Plovdiv, 4002

  • Investigational Site Number 1008005

    Rousse, 7002

  • Investigational Site Number 1008007

    Rousse, 7003

  • Investigational Site Number 1008002

    Smolyan, 4700

  • Investigational Site Number 1008008

    Sofia, 1606

  • Investigational Site Number 1008012

    Sofia, 1632

  • Investigational Site Number 1008003

    Stara Zagora, 6000

  • Investigational Site Number 1008010

    Stara Zagora, 6000

  • Investigational Site Number 1008004

    Varna, 9000

Other trials in Bulgaria

Italy11 sites

  • Investigational Site Number 3808010

    Catania, 95122

  • Investigational Site Number 3808003

    Catania, 95123

  • Investigational Site Number 3808002

    Chieti, 66100

  • Investigational Site Number 3808004

    Milan, 20122

  • Investigational Site Number 3808005

    Milan, 20132

  • Investigational Site Number 3808009

    Pavia, 27100

  • Investigational Site Number 3808008

    Roma, 00133

  • Investigational Site Number 3808001

    Roma, 00168

  • Investigational Site Number 3808007

    Roma, 161

  • Investigational Site Number 3808011

    San Giovanni Rotondo, 71013

  • Investigational Site Number 3808006

    Siena, 53100

Other trials in Italy

Canada10 sites

  • Investigational Site Number 1248001

    Brampton, L6T 0G1

  • Investigational Site Number 1248007

    Burlington, L7M 4Y1

  • Investigational Site Number 1248003

    Newmarket, L3Y 5G8

  • Investigational Site Number 1248010

    Québec, G1N 4V3

  • Investigational Site Number 1248009

    Sherbrooke, J1L 0H8

  • Investigational Site Number 1248002

    Thornhill, L4J 1W3

  • Investigational Site Number 1248004

    Toronto, M3M 3E5

  • Investigational Site Number 1248011

    Toronto, M9W 4L6

  • Investigational Site Number 1248005

    Vancouver, V5Y 3W2

  • Investigational Site Number 1248008

    Victoriaville, G6P 6P6

Other trials in Canada

Spain10 sites

  • Investigational Site Number 7248006

    Barcelona, 8035

  • Investigational Site Number 7248002

    Córdoba, 14011

  • Investigational Site Number 7248005

    Malaga Malaga, 29006

  • Investigational Site Number 7248010

    Santa Coloma de Gramenet, 08923

  • Investigational Site Number 7248009

    Santiago de Compostela, 15706

  • Investigational Site Number 7248004

    Seville, 41010

  • Investigational Site Number 7248008

    Seville, 41013

  • Investigational Site Number 7248001

    Seville, 41071

  • Investigational Site Number 7248003

    Valencia, 46014

  • Investigational Site Number 7248007

    Zaragoza, 50009

Other trials in Spain

Slovakia9 sites

  • Investigational Site Number 7038005

    Bardejov, 085 01

  • Investigational Site Number 7038009

    Bratislava, 8210

  • Investigational Site Number 7038001

    Košice, 4014

  • Investigational Site Number 7038006

    Lučenec, 984 01

  • Investigational Site Number 7038008

    Nové Zámky, 940 01

  • Investigational Site Number 7038004

    Považská Bystrica, 1701

  • Investigational Site Number 7038002

    Rožňava, 048 01

  • Investigational Site Number 7038007

    Sabinov, 08301

  • Investigational Site Number 7038003

    Vrútky, 038 61

Other trials in Slovakia

Latvia8 sites

  • Investigational Site Number 4288004

    Kuldīga, 3301

  • Investigational Site Number 4288008

    Limbaži, 4000

  • Investigational Site Number 4288003

    Ogre, 5001

  • Investigational Site Number 4288007

    Riga, LV -1021

  • Investigational Site Number 4288001

    Riga, LV-1002

  • Investigational Site Number 4288002

    Riga, LV-1011

  • Investigational Site Number 4288006

    Sigulda, LV-2150

  • Investigational Site Number 4288005

    Talsi, LV-3200

Other trials in Latvia

United Kingdom8 sites

  • Investigational Site Number 8268008

    Darlington, DL3 6HX

  • Investigational Site Number 8268004

    Dundee, DD1 9SY

  • Investigational Site Number 8268006

    Exeter, EX2 5DW

  • Investigational Site Number 8268001

    Hull, HU3 2RW

  • Investigational Site Number 8268002

    Huntingdon, PE29 6NT

  • Investigational Site Number 8268007

    Sheffield, S5 7AU

  • Investigational Site Number 8268003

    Southampton, SO30 3JB

  • Investigational Site Number 8268005

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France7 sites

  • Investigational Site Number 2508005

    Corbeil-Essonnes, 91106

  • Investigational Site Number 2508006

    La Roche-sur-Yon, 85925

  • Investigational Site Number 2508007

    La Tronche, 38700

  • Investigational Site Number 2508003

    Mulhouse, 68100

  • Investigational Site Number 2508002

    Nantes, 44093

  • Investigational Site Number 2508001

    Paris, 75018

  • Investigational Site Number 2508004

    Saint-Mandé, 94160

Other trials in France

Mexico7 sites

  • Investigational Site Number 4848002

    Chihuahua City, 31200

  • Investigational Site Number 4848003

    Cuernavaca, 62250

  • Investigational Site Number 4848007

    Durango, Durango, 34080

  • Investigational Site Number 4848011

    Mexico City, 06700

  • Investigational Site Number 4848005

    Monterrey, 07960-6136

  • Investigational Site Number 4848001

    Monterrey, 64020

  • Investigational Site Number 4848012

    Monterrey, 64460

Other trials in Mexico

About this study

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

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.

Being tested
Sotagliflozin, Empagliflozin, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotagliflozinDrug

    Also called SAR439954

    Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.

  • EmpagliflozinDrug

    Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.

  • PlaceboDrug

    Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.

  • PlaceboDrug

    Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.

Study groups in NCT03351478
Study groupRoleWhat they receive
Sotagliflozin 400 mgExperimentalFollowing a 2-week run-in period, sotagliflozin 400 mg (milligrams) administered as two 200 mg tablets and one placebo capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day for up to 26 weeks.
Receives: Drug: Sotagliflozin; Drug: Placebo
Empagliflozin 25 mgActive comparatorFollowing a 2-week run-in period, placebo matching sotagliflozin administered as two tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin 25 mg, once daily before the first meal of the day for up to 26 weeks.
Receives: Drug: Empagliflozin; Drug: Placebo
PlaceboPlacebo comparatorFollowing a 2-week run-in period, placebo was given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day for up to 26 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26

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

    Measured: Baseline, Week 26

Secondary outcomes (7)

  1. 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.

    Measured: Baseline, Week 12

  2. Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Mixed Meal at Week 26

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 26

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

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 26

  4. Change From Baseline in Body Weight at Week 26

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 26

  5. Change From Baseline in Sitting SBP at Week 12 for All Participants

    An ANCOVA model was used for the analysis.

    Measured: Baseline, Week 12

  6. Percentage of Participants With HbA1c <6.5% at Week 26

    Measured: Week 26

  7. Percentage of Participants With HbA1c <7.0% at Week 26

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start27 Nov 2017
  3. Primary completion16 May 2019
  4. Study completion16 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
770 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03351478
Sponsor's protocol ID
EFC14867
Other IDs
2016-001803-22, U1111-1190-7607, 2016
Acronym
SOTA-EMPA
Status last verified
Apr 2021
First submitted
20 Nov 2017
Last updated
11 May 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin and Empagliflozin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 160 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 sites in United States, Russia, Czechia, Bulgaria, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) % at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03351478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in