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

Last updated: June 3, 2021
Sponsor: Lexicon Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03242252
EFC14837
2016-004889-26
U1111-1187-8662
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria :

  • Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) anddocumented moderate renal insufficiency defined by an estimated glomerular filtrationrate (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 inaccordance with local regulations.

Exclusion

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 whoare 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 heartfailure New York Heart Association IV), respiratory, hepatic, neurological,psychiatric, or active malignant tumor or other major systemic disease or patientswith short life expectancy that, according to the Investigator, will preclude theirsafe participation in this study, or will make implementation of the protocol orinterpretation of the study results difficult.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis andgangrene) identified during the Screening period, and still requiring treatment atRandomization. The above information is not intended to contain all considerations relevant to aparticipant's potential participation in a clinical trial.

Study Design

Total Participants: 787
Study Start date:
August 16, 2017
Estimated Completion Date:
October 25, 2019

Study 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.

Connect with a study center

  • Investigational Site Number 0324001

    Buenos Aires, C1429BWN
    Argentina

    Site Not Available

  • Investigational Site Number 0324002

    Caba, 1425DES
    Argentina

    Site Not Available

  • Investigational Site Number 0324005

    Ciudad Autónoma Buenos Aires, 1205
    Argentina

    Site Not Available

  • Investigational Site Number 0324008

    Cordoba, 5000
    Argentina

    Site Not Available

  • Investigational Site Number 0324004

    Coronel Suarez, B7540GHD
    Argentina

    Site Not Available

  • Investigational Site Number 0324006

    Córdoba, X5008HHW
    Argentina

    Site Not Available

  • Investigational Site Number 0324009

    La Plata, 1900
    Argentina

    Site Not Available

  • Investigational Site Number 0324003

    Lanus, B1824KAJ
    Argentina

    Site Not Available

  • Investigational Site Number 0324007

    Mar Del Plata, B7600FYK
    Argentina

    Site Not Available

  • Investigational Site Number 0764007

    Belo Horizonte, 30150-240
    Brazil

    Site Not Available

  • Investigational Site Number 0764001

    Belém, 66073-005
    Brazil

    Site Not Available

  • Investigational Site Number 0764002

    Curitiba, 80030-480
    Brazil

    Site Not Available

  • Investigational Site Number 0764008

    Curitiba, 80810-040
    Brazil

    Site Not Available

  • Investigational Site Number 0764003

    Fortaleza, 60170-195
    Brazil

    Site Not Available

  • Investigational Site Number 0764005

    Rio De Janeiro, 22271-100
    Brazil

    Site Not Available

  • Investigational Site Number 0764006

    Sao Paulo, 04266-010
    Brazil

    Site Not Available

  • Investigational Site Number 0764004

    São Paulo, 01244-030
    Brazil

    Site Not Available

  • Investigational Site Number 1244007

    Brampton, L6S 0C6
    Canada

    Site Not Available

  • Investigational Site Number 1244004

    Burlington, L7R 1A4
    Canada

    Site Not Available

  • Investigational Site Number 1244005

    Etobicoke, M9R 4E1
    Canada

    Site Not Available

  • Investigational Site Number 1244006

    Laval, H7T 2P5
    Canada

    Site Not Available

  • Investigational Site Number 1244009

    Montreal, H4A 2C6
    Canada

    Site Not Available

  • Investigational Site Number 1244010

    Ottawa, K2J 0V2
    Canada

    Site Not Available

  • Investigational Site Number 1244003

    Thornhill, L4J 8L7
    Canada

    Site Not Available

  • Investigational Site Number 1244002

    Toronto, M4C 5T2
    Canada

    Site Not Available

  • Investigational Site Number 1244008

    Toronto, M4G 3E8
    Canada

    Site Not Available

  • Investigational Site Number 1244001

    Vancouver, V5Y 3W2
    Canada

    Site Not Available

  • Investigational Site Number 1704007

    Barranquilla, 80020
    Colombia

    Site Not Available

  • Investigational Site Number 1704008

    Barranquilla, 080001
    Colombia

    Site Not Available

  • Investigational Site Number 1704004

    Bogota, 110221
    Colombia

    Site Not Available

  • Investigational Site Number 1704009

    Bogota, 110911
    Colombia

    Site Not Available

  • Investigational Site Number 1704006

    Ibague, 730006
    Colombia

    Site Not Available

  • Investigational Site Number 1704001

    Manizales, 170004
    Colombia

    Site Not Available

  • Investigational Site Number 1704002

    Medellin / Antioquia, 50021
    Colombia

    Site Not Available

  • Investigational Site Number 1704005

    Zipaquira, 250252
    Colombia

    Site Not Available

  • Investigational Site Number 2764001

    Frankfurt Am Main, 60596
    Germany

    Site Not Available

  • Investigational Site Number 2764002

    Hamburg, 21073
    Germany

    Site Not Available

  • Investigational Site Number 2764003

    Muenster, 48145
    Germany

    Site Not Available

  • Investigational Site Number 2764003

    Münster, 48145
    Germany

    Site Not Available

  • Investigational Site Number 3484008

    Baja, 6500
    Hungary

    Site Not Available

  • Investigational Site Number 3484012

    Baja, 6500
    Hungary

    Site Not Available

  • Investigational Site Number 3484002

    Balatonfured, 8230
    Hungary

    Site Not Available

  • Investigational Site Number 3484007

    Budapest, 1033
    Hungary

    Site Not Available

  • Investigational Site Number 3484005

    Debrecen, 4032
    Hungary

    Site Not Available

  • Investigational Site Number 3484011

    Debrecen, 4025
    Hungary

    Site Not Available

  • Investigational Site Number 3484001

    Gyula, 5700
    Hungary

    Site Not Available

  • Investigational Site Number 3484010

    Nyiregyhaza, 4405
    Hungary

    Site Not Available

  • Investigational Site Number 3484013

    Nyregyhza, 4400
    Hungary

    Site Not Available

  • Investigational Site Number 3484004

    Pécs, 7623
    Hungary

    Site Not Available

  • Investigational Site Number 3764001

    Ashkelon, 7830604
    Israel

    Site Not Available

  • Investigational Site Number 3764010

    Be'Er-Sheva, 84101
    Israel

    Site Not Available

  • Investigational Site Number 3764013

    Be'er Ya'aqov, 70300
    Israel

    Site Not Available

  • Investigational Site Number 3764007

    Haifa, 31096
    Israel

    Site Not Available

  • Investigational Site Number 3764009

    Kfar-Saba, 44281
    Israel

    Site Not Available

  • Investigational Site Number 3764011

    Kfar-Saba, 44281
    Israel

    Site Not Available

  • Investigational Site Number 3764003

    Nahariya, 22100
    Israel

    Site Not Available

  • Investigational Site Number 3764004

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Investigational Site Number 3764006

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Investigational Site Number 3764005

    Rehovot, 76100
    Israel

    Site Not Available

  • Investigational Site Number 3764002

    Tel Aviv, 61480
    Israel

    Site Not Available

  • Investigational Site Number 3764008

    Zefat, 13100
    Israel

    Site Not Available

  • Investigational Site Number 3764013

    Zerifin, 70300
    Israel

    Site Not Available

  • Investigational Site Number 3804007

    Catania, 95123
    Italy

    Site Not Available

  • Investigational Site Number 3804004

    Milano, 20132
    Italy

    Site Not Available

  • Investigational Site Number 3804005

    Milano, 20122
    Italy

    Site Not Available

  • Investigational Site Number 3804008

    Naples, 80131
    Italy

    Site Not Available

  • Investigational Site Number 3804002

    Napoli, 80138
    Italy

    Site Not Available

  • Investigational Site Number 3804001

    Pavia, 27100
    Italy

    Site Not Available

  • Investigational Site Number 3804003

    Roma, 00168
    Italy

    Site Not Available

  • Investigational Site Number 3804003

    Rome, 00168
    Italy

    Site Not Available

  • Investigational Site Number 3804006

    Siena, 53100
    Italy

    Site Not Available

  • Investigational Site Number 4844009

    Chihuahua Chihuahua, 31217
    Mexico

    Site Not Available

  • Investigational Site Number 4844008

    Durango, Durango, 34080
    Mexico

    Site Not Available

  • Investigational Site Number 4844001

    Guadalajara, 44210
    Mexico

    Site Not Available

  • Investigational Site Number 4844003

    Guadalajara, 44600
    Mexico

    Site Not Available

  • Investigational Site Number 4844006

    Merida, Yucatan, 97130
    Mexico

    Site Not Available

  • Investigational Site Number 4844005

    Monterrey, 64460
    Mexico

    Site Not Available

  • Investigational Site Number 4844006

    Mérida, 97130
    Mexico

    Site Not Available

  • Investigational Site Number 4844004

    Xalapa, 91020
    Mexico

    Site Not Available

  • Investigational Site Number 6164002

    Bia?Ystok, 15-435
    Poland

    Site Not Available

  • Investigational Site Number 6164002

    Białystok, 15-435
    Poland

    Site Not Available

  • Investigational Site Number 6164006

    Katowice, 40-081
    Poland

    Site Not Available

  • Investigational Site Number 6164004

    Krakow, 31-209
    Poland

    Site Not Available

  • Investigational Site Number 6164008

    Krakow, 31-530
    Poland

    Site Not Available

  • Investigational Site Number 6164009

    Krakow, 30-363
    Poland

    Site Not Available

  • Investigational Site Number 6164010

    Krakow, 30-033
    Poland

    Site Not Available

  • Investigational Site Number 6164011

    Lodz, 92-213
    Poland

    Site Not Available

  • Investigational Site Number 6164005

    Oswiecim, 32-600
    Poland

    Site Not Available

  • Investigational Site Number 6164003

    Rzeszow, 35-055
    Poland

    Site Not Available

  • Investigational Site Number 6164012

    Skierniewice, 96-100
    Poland

    Site Not Available

  • Investigational Site Number 6164007

    Warszawa, 02-507
    Poland

    Site Not Available

  • Investigational Site Number 6424001

    Bacau, 600238
    Romania

    Site Not Available

  • Investigational Site Number 6424002

    Bacau, 600154
    Romania

    Site Not Available

  • Investigational Site Number 6424009

    Bucure?Ti, 013764
    Romania

    Site Not Available

  • Investigational Site Number 6424004

    Bucuresti, 010825
    Romania

    Site Not Available

  • Investigational Site Number 6424009

    Bucuresti, 013764
    Romania

    Site Not Available

  • Investigational Site Number 6424010

    Bucuresti, 040172
    Romania

    Site Not Available

  • Investigational Site Number 6424006

    Hunedoara, 331057
    Romania

    Site Not Available

  • Investigational Site Number 6424007

    Ia?I, 700503
    Romania

    Site Not Available

  • Investigational Site Number 6424011

    Oradea, 410159
    Romania

    Site Not Available

  • Investigational Site Number 6424003

    Targu-Mures, 540142
    Romania

    Site Not Available

  • Investigational Site Number 6434003

    Chelyabinsk, 454047
    Russian Federation

    Site Not Available

  • Investigational Site Number 6434005

    Kemerovo, 650002
    Russian Federation

    Site Not Available

  • Investigational Site Number 6434002

    Krasnodar, 3500
    Russian Federation

    Site Not Available

  • Investigational Site Number 6434004

    Novosibirsk, 630091
    Russian Federation

    Site Not Available

  • Investigational Site Number 6434001

    St. Petersburg, 194358
    Russian Federation

    Site Not Available

  • Investigational Site Number 6434006

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Investigational Site Number 7104002

    Cape Town, 7570
    South Africa

    Site Not Available

  • Investigational Site Number 7104008

    Cape Town, 7531
    South Africa

    Site Not Available

  • Investigational Site Number 7104007

    Goodwood, 7463
    South Africa

    Site Not Available

  • Investigational Site Number 7104001

    Johannesburg, 1685
    South Africa

    Site Not Available

  • Investigational Site Number 7104005

    Johannesburg, 2198
    South Africa

    Site Not Available

  • Investigational Site Number 7104010

    Johannesburg, 2188
    South Africa

    Site Not Available

  • Investigational Site Number 7104004

    Parow, 7500
    South Africa

    Site Not Available

  • Investigational Site Number 7104006

    Pretoria, 0002
    South Africa

    Site Not Available

  • Investigational Site Number 7104009

    Pretoria Gauteng, 0181
    South Africa

    Site Not Available

  • Investigational Site Number 7104011

    Worcester, 6850
    South Africa

    Site Not Available

  • Investigational Site Number 7244011

    Barcelona, 08035
    Spain

    Site Not Available

  • Investigational Site Number 7244007

    Granada, 18012
    Spain

    Site Not Available

  • Investigational Site Number 7244003

    Madrid, 28041
    Spain

    Site Not Available

  • Investigational Site Number 7244003

    Madrid Madrid, 28041
    Spain

    Site Not Available

  • Investigational Site Number 7244010

    Málaga Málaga, 29010
    Spain

    Site Not Available

  • Investigational Site Number 7244006

    Palma De Mallorca, 07010
    Spain

    Site Not Available

  • Investigational Site Number 7244008

    Sabadell, Barcelona, 8208
    Spain

    Site Not Available

  • Investigational Site Number 7244001

    Sevilla, 41071
    Spain

    Site Not Available

  • Investigational Site Number 7244002

    Valencia, 46014
    Spain

    Site Not Available

  • Investigational Site Number 7244002

    Valencia Valencia, 46014
    Spain

    Site Not Available

  • Investigational Site Number 7244009

    Zaragoza, 50009
    Spain

    Site Not Available

  • Investigational Site Number 8044004

    Dnipro,
    Ukraine

    Site Not Available

  • Investigational Site Number 8044004

    Dnipropetrovsk, 49005
    Ukraine

    Site Not Available

  • Investigational Site Number 8044007

    Kharkiv, 61106
    Ukraine

    Site Not Available

  • Investigational Site Number 8044010

    Kharkiv, 61166
    Ukraine

    Site Not Available

  • Investigational Site Number 8044007

    Kharkov,
    Ukraine

    Site Not Available

  • Investigational Site Number 8044003

    Kiev, 04050
    Ukraine

    Site Not Available

  • Investigational Site Number 8044008

    Kiev, 02002
    Ukraine

    Site Not Available

  • Investigational Site Number 8044001

    Kyiv, 03037
    Ukraine

    Site Not Available

  • Investigational Site Number 8044006

    Kyiv, 03049
    Ukraine

    Site Not Available

  • Investigational Site Number 8044009

    Kyiv, 02091
    Ukraine

    Site Not Available

  • Investigational Site Number 8044005

    Lviv, 79010
    Ukraine

    Site Not Available

  • Investigational Site Number 8044002

    Zaporizhia, 69600
    Ukraine

    Site Not Available

  • Investigational Site Number 8404018

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Investigational Site Number 8404045

    Guntersville, Alabama 35976-2206
    United States

    Site Not Available

  • Investigational Site Number 8404004

    Phoenix, Arizona 85018-2701
    United States

    Site Not Available

  • Investigational Site Number 8404022

    Phoenix, Arizona 85050-7500
    United States

    Site Not Available

  • Investigational Site Number 8404007

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Investigational Site Number 8404023

    Chula Vista, California 91910
    United States

    Site Not Available

  • Investigational Site Number 8404044

    Gold River, California 95670
    United States

    Site Not Available

  • Investigational Site Number 8404011

    Los Angeles, California 90057
    United States

    Site Not Available

  • Investigational Site Number 8404003

    Norco, California 92860
    United States

    Site Not Available

  • Investigational Site Number 8404025

    Northridge, California 91324
    United States

    Site Not Available

  • Investigational Site Number 8404038

    San Dimas, California 91713
    United States

    Site Not Available

  • Investigational Site Number 8404017

    Colorado Springs, Colorado 80920-8075
    United States

    Site Not Available

  • Investigational Site Number 8404019

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Investigational Site Number 8404001

    DeLand, Florida 32720-0834
    United States

    Site Not Available

  • Investigational Site Number 8404006

    Ocoee, Florida 34761-4547
    United States

    Site Not Available

  • Investigational Site Number 8404064

    Orlando, Florida 32806
    United States

    Site Not Available

  • Investigational Site Number 8404043

    Ormond Beach, Florida 32174-8187
    United States

    Site Not Available

  • Investigational Site Number 8404013

    Palmetto Bay, Florida 33157-5503
    United States

    Site Not Available

  • Investigational Site Number 8404016

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Investigational Site Number 8404040

    Wauconda, Illinois 60084-2452
    United States

    Site Not Available

  • Investigational Site Number 8404058

    Sellersburg, Indiana 47172-8932
    United States

    Site Not Available

  • Investigational Site Number 8404036

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Investigational Site Number 8404020

    New Orleans, Louisiana 70119-6302
    United States

    Site Not Available

  • Investigational Site Number 8404014

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Investigational Site Number 8404032

    Papillion, Nebraska 68046-3136
    United States

    Site Not Available

  • Investigational Site Number 8404048

    Hackensack, New Jersey 07601-1963
    United States

    Site Not Available

  • Investigational Site Number 8404009

    Bronx, New York 10455
    United States

    Site Not Available

  • Investigational Site Number 8404074

    New York, New York 00000
    United States

    Site Not Available

  • Investigational Site Number 8404009

    The Bronx, New York 10455
    United States

    Site Not Available

  • Investigational Site Number 8404051

    Wilmington, North Carolina 28401-6638
    United States

    Site Not Available

  • Investigational Site Number 8404028

    Winston-Salem, North Carolina 27103-3914
    United States

    Site Not Available

  • Investigational Site Number 8404029

    Winston-Salem, North Carolina 27103-4027
    United States

    Site Not Available

  • Investigational Site Number 8404026

    Dayton, Ohio 45419-4336
    United States

    Site Not Available

  • Investigational Site Number 8404052

    Lansdale, Pennsylvania 19446-1002
    United States

    Site Not Available

  • Investigational Site Number 8404031

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Investigational Site Number 8404024

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Investigational Site Number 8404021

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Investigational Site Number 8404056

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Investigational Site Number 8404015

    Austin, Texas 78726-4061
    United States

    Site Not Available

  • Investigational Site Number 8404050

    Austin, Texas 78731
    United States

    Site Not Available

  • Investigational Site Number 8404060

    Austin, Texas 78749
    United States

    Site Not Available

  • Investigational Site Number 8404005

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Investigational Site Number 8404035

    Dallas, Texas 75208
    United States

    Site Not Available

  • Investigational Site Number 8404039

    Houston, Texas 77058
    United States

    Site Not Available

  • Investigational Site Number 8404055

    Houston, Texas 77099
    United States

    Site Not Available

  • Investigational Site Number 8404012

    Hurst, Texas 76054
    United States

    Site Not Available

  • Investigational Site Number 8404033

    Lampasas, Texas 76550-1820
    United States

    Site Not Available

  • Investigational Site Number 8404053

    McAllen, Texas 78504
    United States

    Site Not Available

  • Investigational Site Number 8404057

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Investigational Site Number 8404010

    San Antonio, Texas 78249-2782
    United States

    Site Not Available

  • Investigational Site Number 8404059

    San Antonio, Texas 78212
    United States

    Site Not Available

  • Investigational Site Number 8404008

    Layton, Utah 84041-1200
    United States

    Site Not Available

  • Investigational Site Number 8404042

    Renton, Washington 98057
    United States

    Site Not Available

  • Investigational Site Number 8404041

    Seattle, Washington 98105
    United States

    Site Not Available

  • Investigational Site Number 8404047

    Kenosha, Wisconsin 53144
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.