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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 (SOTA-EMPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03351478
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Sotagliflozin (SAR439954) Drug: Empagliflozin Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : May 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sotagliflozin
Sotagliflozin will be given as two tablets and one placebo capsule (identical to empagliflozin capsule in appearance), once daily before the first meal of the day.
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral


Drug: Placebo

Pharmaceutical form: capsule

Route of administration: oral


Active Comparator: Empagliflozin
Empagliflozin will be given as two placebo tablets (identical to sotagliflozin in appearance) and one capsule of empagliflozin, once daily before the first meal of the day.
Drug: Empagliflozin

Pharmaceutical form: capsule

Route of administration: oral


Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral


Placebo Comparator: Placebo
Placebo given as two placebo tablets (identical to sotagliflozin) and one placebo capsule (identical to empagliflozin) once daily before the first meal of the day.
Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral


Drug: Placebo

Pharmaceutical form: capsule

Route of administration: oral





Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline to week 26 ]
    Absolute change from baseline to week 26 in Hemoglobin A1 (HbA1c)


Secondary Outcome Measures :
  1. Change in sitting SBP in patients with SBP ≥130 mmHg at Baseline [ Time Frame: Baseline to week 12 ]
    Absolute change from baseline to week 12 in sitting systolic blood pressure (SBP)

  2. Change in 2-hour PPG following a MMTT [ Time Frame: Baseline to week 26 ]
    Absolute change in 2-hour post prandial glucose (PPG) following a mixed meal tolerance test (MMTT) from baseline to week 26

  3. Change in FPG [ Time Frame: Baseline to week 26 ]
    Absolute change in fasting plasma glucose (FPG) from baseline to week 26

  4. Change in body weight [ Time Frame: Baseline to week 26 ]
    Absolute change in body weight from baseline to week 26

  5. Change in sitting SBP in all patients [ Time Frame: Baseline to week 12 ]
    Absolute change from baseline to week 12 in sitting systolic blood pressure (SBP) in all patients

  6. Patients with HbA1c <6.5% [ Time Frame: At week 26 ]
    Proportion of patients with Hemoglobin A1c (HbA1c) <6.5% at week 26

  7. Patients with HbA1c <7.0% [ Time Frame: At week 26 ]
    Proportion of patients with Hemoglobin A1c (HbA1c) <7.0% at week 26



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients 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/m² or >45 kg/m² at Screening.
  • Use of any antidiabetic drug other than DPP4 inhibitors and metformin within 12 weeks preceding the Screening Visit.
  • Patients 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 screening visit.
  • Patients 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 patients with short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make 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.
  • Patients with contraindication to empagliflozin as per local labeling.
  • Patients with contraindication to metformin as per local labeling.
  • 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 types 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 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/mm3 (or according to ethnic group) and/or platelets <100 000/mm3;
  • Amylase and/or lipase >3 times the ULN;
  • Patients 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 m2 in US; <60 mL/min/1.73 m2 in EU).
  • Secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
  • If the patient 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 patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351478


Locations
Hide Hide 149 study locations
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United States, Alabama
Investigational Site Number 8408035
Birmingham, Alabama, United States, 35205
Investigational Site Number 8408050
Birmingham, Alabama, United States, 35233
Investigational Site Number 8408028
Sheffield, Alabama, United States, 35660
United States, California
Investigational Site Number 8408047
Hawaiian Gardens, California, United States, 90716
Investigational Site Number 8408031
Spring Valley, California, United States, 91978
Investigational Site Number 8408067
Van Nuys, California, United States, 91405
United States, Colorado
Investigational Site Number 8408069
Northglenn, Colorado, United States, 80234
United States, Florida
Investigational Site Number 8408009
Miami, Florida, United States, 33183-4825
Investigational Site Number 8408049
Ocoee, Florida, United States, 34761
Investigational Site Number 8408005
Orlando, Florida, United States, 32810
Investigational Site Number 8408040
Orlando, Florida, United States, 32825
Investigational Site Number 8408019
Palmetto Bay, Florida, United States, 33157-5503
Investigational Site Number 8408064
Port Charlotte, Florida, United States, 33952
United States, Georgia
Investigational Site Number 8408061
Columbus, Georgia, United States, 31904
Investigational Site Number 8408074
Macon, Georgia, United States, 31210
Investigational Site Number 8408079
Savannah, Georgia, United States, 31406
Investigational Site Number 8408059
Statesboro, Georgia, United States, 30461-0845
United States, Idaho
Investigational Site Number 8408051
Blackfoot, Idaho, United States, 83221
United States, Illinois
Investigational Site Number 8408033
Elgin, Illinois, United States, 60124
United States, Louisiana
Investigational Site Number 8408003
New Orleans, Louisiana, United States, 70124
United States, Maryland
Investigational Site Number 8408002
Rockville, Maryland, United States, 20852
United States, Massachusetts
Investigational Site Number 8408044
Fall River, Massachusetts, United States, 02721-3005
United States, Michigan
Investigational Site Number 8408008
Flint, Michigan, United States, 48532
United States, New York
Investigational Site Number 8408027
West Seneca, New York, United States, 14224
United States, North Carolina
Investigational Site Number 8408037
Fayetteville, North Carolina, United States, 28314
Investigational Site Number 8408053
Greensboro, North Carolina, United States, 27408-7042
Investigational Site Number 8408012
Greensboro, North Carolina, United States, 27408
Investigational Site Number 8408013
Salisbury, North Carolina, United States, 28144-2742
United States, Oklahoma
Investigational Site Number 8408045
Oklahoma City, Oklahoma, United States, 73104-3252
United States, Rhode Island
Investigational Site Number 8408068
Warwick, Rhode Island, United States, 02888-3360
United States, South Carolina
Investigational Site Number 8408060
Fort Mill, South Carolina, United States, 29707-4514
United States, Tennessee
Investigational Site Number 8408018
Jefferson City, Tennessee, United States, 37760
Investigational Site Number 8408010
Knoxville, Tennessee, United States, 37912-4707
Investigational Site Number 8408038
Knoxville, Tennessee, United States, 37938
United States, Texas
Investigational Site Number 8408072
Brownsville, Texas, United States, 78520-7512
Investigational Site Number 8408056
Dallas, Texas, United States, 75208
Investigational Site Number 8408082
Dallas, Texas, United States, 75230
Investigational Site Number 8408052
Dallas, Texas, United States, 75231-3428
Investigational Site Number 8408001
Houston, Texas, United States, 77004
Investigational Site Number 8408032
Houston, Texas, United States, 77004
Investigational Site Number 8408016
Houston, Texas, United States, 77040
Investigational Site Number 8408017
Houston, Texas, United States, 77058
Investigational Site Number 8408036
Houston, Texas, United States, 77061
Investigational Site Number 8408022
Houston, Texas, United States, 77099
Investigational Site Number 8408029
Katy, Texas, United States, 77450
Investigational Site Number 8408054
McAllen, Texas, United States, 78504
Investigational Site Number 8408039
Mesquite, Texas, United States, 75149
Investigational Site Number 8408042
Plano, Texas, United States, 75024
Investigational Site Number 8408011
San Antonio, Texas, United States, 78229-3818
Investigational Site Number 8408041
Schertz, Texas, United States, 78154
United States, Utah
Investigational Site Number 8408007
Bountiful, Utah, United States, 84010-7717
Investigational Site Number 8408026
Holladay, Utah, United States, 84117
United States, Virginia
Investigational Site Number 8408006
Burke, Virginia, United States, 22015
Investigational Site Number 8408004
Manassas, Virginia, United States, 20110
Bulgaria
Investigational Site Number 1008011
Gabrovo, Bulgaria, 5300
Investigational Site Number 1008006
Plovdiv, Bulgaria, 4000
Investigational Site Number 1008001
Plovdiv, Bulgaria, 4002
Investigational Site Number 1008005
Ruse, Bulgaria, 7002
Investigational Site Number 1008007
Ruse, Bulgaria, 7003
Investigational Site Number 1008002
Smolyan, Bulgaria, 4700
Investigational Site Number 1008008
Sofia, Bulgaria, 1606
Investigational Site Number 1008012
Sofia, Bulgaria, 1632
Investigational Site Number 1008003
Stara Zagora, Bulgaria, 6000
Investigational Site Number 1008010
Stara Zagora, Bulgaria, 6000
Investigational Site Number 1008004
Varna, Bulgaria, 9000
Canada
Investigational Site Number 1248001
Brampton, Canada, L6T 0G1
Investigational Site Number 1248007
Burlington, Canada, L7M 4Y1
Investigational Site Number 1248003
Newmarket, Canada, L3Y 5G8
Investigational Site Number 1248010
Quebec, Canada, G1N 4V3
Investigational Site Number 1248009
Sherbrooke, Canada, J1L 0H8
Investigational Site Number 1248002
Thornhill, Canada, L4J 1W3
Investigational Site Number 1248004
Toronto, Canada, M3M 3E5
Investigational Site Number 1248011
Toronto, Canada, M9W 4L6
Investigational Site Number 1248005
Vancouver, Canada, V5Y 3W2
Investigational Site Number 1248008
Victoriaville, Canada, G6P 6P6
Czechia
Investigational Site Number 2038007
Brandys, Czechia, 250 01
Investigational Site Number 2038003
Havirov, Czechia, 736 01
Investigational Site Number 2038004
Krnov, Czechia, 794 01
Investigational Site Number 2038011
Ostrava, Czechia, 710 00
Investigational Site Number 2038006
Pardubice, Czechia, 530 02
Investigational Site Number 2038010
Plzen, Czechia, 363 01
Investigational Site Number 2038005
Prague, Czechia, 18100
Investigational Site Number 2038001
Praha 10 - Uhrineves, Czechia, 104 00
Investigational Site Number 2038009
Praha 1, Czechia, 110 00
Investigational Site Number 2038002
Praha 4, Czechia, 149 00
Investigational Site Number 2038008
Praha 9, Czechia, 190 14
France
Investigational Site Number 2508005
Corbeil-Essonnes, France, 91106
Investigational Site Number 2508006
La Roche Sur Yon, France, 85925
Investigational Site Number 2508002
Nantes Cedex 1, France, 44093
Italy
Investigational Site Number 3808002
Chieti, Italy, 66100
Investigational Site Number 3808004
Milano, Italy, 20122
Investigational Site Number 3808005
Milano, Italy, 20132
Investigational Site Number 3808009
Pavia, Italy, 27100
Investigational Site Number 3808008
Roma, Italy, 00133
Investigational Site Number 3808001
Roma, Italy, 00168
Investigational Site Number 3808007
Roma, Italy, 161
Investigational Site Number 3808011
San Giovanni Rotondo, Italy, 71013
Investigational Site Number 3808006
Siena, Italy, 53100
Latvia
Investigational Site Number 4288004
Kuldiga, Latvia, 3301
Investigational Site Number 4288008
Limbazi, Latvia, 4000
Investigational Site Number 4288003
Ogre, Latvia, 5001
Investigational Site Number 4288001
Riga, Latvia, LV-1002
Investigational Site Number 4288007
Riga, Latvia, LV-1006
Investigational Site Number 4288002
Riga, Latvia, LV-1011
Investigational Site Number 4288006
Sigulda, Latvia, LV-2150
Investigational Site Number 4288005
Talsi, Latvia, LV-3200
Mexico
Investigational Site Number 4848002
Chihuahua, Mexico, 31200
Investigational Site Number 4848003
Cuernavaca, Mexico, 62250
Investigational Site Number 4848007
Durango, Durango, Mexico, 34080
Investigational Site Number 4848011
Mexico City, Mexico, 06700
Investigational Site Number 4848005
Monterrey, Mexico, 07960-6136
Investigational Site Number 4848001
Monterrey, Mexico, 64020
Investigational Site Number 4848012
Monterrey, Mexico, 64460
Russian Federation
Investigational Site Number 6438008
Chelyabinsk, Russian Federation, 454047
Investigational Site Number 6438006
Dzerzhinsky, Russian Federation, 140091
Investigational Site Number 6438009
Kemerovo, Russian Federation, 650002
Investigational Site Number 6438010
Novosibirsk, Russian Federation, 630091
Investigational Site Number 6438013
Saint-Petersburg, Russian Federation, 190013
Investigational Site Number 6438003
Saint-Petersburg, Russian Federation, 192012
Investigational Site Number 6438002
Saint-Petersburg, Russian Federation, 194358
Investigational Site Number 6438005
Saint-Petersburg, Russian Federation, 195213
Investigational Site Number 6438001
Saint-Petersburg, Russian Federation, 196601
Investigational Site Number 6438012
Saratov, Russian Federation, 410054
Investigational Site Number 6438014
St. Petersburg, Russian Federation, 194354
Investigational Site Number 6438015
Volgograd, Russian Federation, 400001
Investigational Site Number 6438007
Vsevolozhsk, Russian Federation, 188643
Investigational Site Number 6438011
Yaroslavl, Russian Federation, 150002
Slovakia
Investigational Site Number 7038005
Bardejov, Slovakia, 085 01
Investigational Site Number 7038009
Bratislava, Slovakia, 8210
Investigational Site Number 7038001
Kosice, Slovakia, 4014
Investigational Site Number 7038006
Lucenec, Slovakia, 984 01
Investigational Site Number 7038008
Nove Zamky, Slovakia, 940 01
Investigational Site Number 7038004
Povazska Bystrica, Slovakia, 1701
Investigational Site Number 7038002
Roznava, Slovakia, 048 01
Investigational Site Number 7038007
Sabinov, Slovakia, 08301
Investigational Site Number 7038003
Vrutky, Slovakia, 038 61
Spain
Investigational Site Number 7248006
Barcelona, Spain, 8035
Investigational Site Number 7248005
Malaga Malaga, Spain, 29006
Investigational Site Number 7248004
Sevilla, Spain, 41010
Investigational Site Number 7248008
Sevilla, Spain, 41013
Investigational Site Number 7248001
Sevilla, Spain, 41071
Investigational Site Number 7248003
Valencia Valencia, Spain, 46014
Investigational Site Number 7248007
Zaragoza, Spain, 50009
United Kingdom
Investigational Site Number 8268004
Dundee, United Kingdom, DD1 9SY
Investigational Site Number 8268006
Exeter, United Kingdom, EX2 5DW
Investigational Site Number 8268001
Hull, United Kingdom, HU3 2RW
Investigational Site Number 8268002
Huntingdon, United Kingdom, PE29 6NT
Investigational Site Number 8268007
Sheffield, United Kingdom, S5 7AU
Investigational Site Number 8268003
Southampton, United Kingdom, SO30 3JB
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03351478    
Other Study ID Numbers: EFC14867
2016-001803-22 ( EudraCT Number )
U1111-1190-7607 ( Other Identifier: UTN )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Empagliflozin
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action