A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control (SOTA-CKD4)

June 3, 2021 updated by: Lexicon Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control

Primary Objective:

To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment

Secondary Objectives:

  • To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c
  • To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo
  • To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425DES
        • Investigational Site Number 0325001
      • Launs Este, Argentina, B1824KAJ
        • Investigational Site Number 0325003
      • Mar Del Plata, Argentina, B7600
        • Investigational Site Number 0325004
  • Brazil
      • Belém, Brazil, 66073-005
        • Investigational Site Number 0765003
      • Fortaleza, Brazil, 60170-195
        • Investigational Site Number 0765001
      • Rio De Janeiro, Brazil, 22271-100
        • Investigational Site Number 0765004
      • Sao Paulo, Brazil, 01244-030
        • Investigational Site Number 0765002
  • Colombia
      • Barranquilla, Colombia, 80020
        • Investigational Site Number 1705004
      • Bogota, Colombia, 110221
        • Investigational Site Number 1705005
      • Manizales, Colombia, 170004
        • Investigational Site Number 1705002
      • Zipaquira, Colombia, 250252
        • Investigational Site Number 1705001
  • Germany
      • Frankfurt Am Main, Germany, 60596
        • Investigational Site Number 2765001
      • Hannover, Germany, 30625
        • Investigational Site Number 2765003
      • Münster, Germany, 48145
        • Investigational Site Number 2765004
  • Hungary
      • Baja, Hungary, 6500
        • Investigational Site Number 3485005
      • Debrecen, Hungary, 4032
        • Investigational Site Number 3485007
      • Pécs, Hungary, 7624
        • Investigational Site Number 3485004
  • Israel
      • Ashkelon, Israel, 78278
        • Investigational Site Number 3765002
      • Haifa, Israel, 31096
        • Investigational Site Number 3765001
      • Kfar-Saba, Israel, 44281
        • Investigational Site Number 3765007
      • Ramat Gan, Israel, 52621
        • Investigational Site Number 3765005
      • Rehovot, Israel, 7642001
        • Investigational Site Number 3765004
      • Tel Aviv, Israel, 61480
        • Investigational Site Number 3765003
      • Zefat, Israel, 13100
        • Investigational Site Number 3765006
  • Italy
      • Catania, Italy, 95123
        • Investigational Site Number 3805003
      • Milano, Italy, 20132
        • Investigational Site Number 3805005
      • Napoli, Italy, 00181
        • Investigational Site Number 3805006
      • Napoli, Italy, 80138
        • Investigational Site Number 3805002
      • Pavia, Italy, 27100
        • Investigational Site Number 3805001
      • Roma, Italy, 00168
        • Investigational Site Number 3805004
  • Mexico
      • Guadalajara, Mexico, 44210
        • Investigational Site Number 4845001
      • Guadalajara, Mexico, 44600
        • Investigational Site Number 4845004
      • Guadalajara Jalisco, Mexico, 44130
        • Investigational Site Number 4845007
      • Merida, Yucatan, Mexico, 97130
        • Investigational Site Number 4845008
      • Monterrey, N.L, Mexico, 64460
        • Investigational Site Number 4845006
      • Morelia, Mexico, 58260
        • Investigational Site Number 4845003
      • Queretaro, Mexico, 76000
        • Investigational Site Number 4845002
      • Xalapa, Mexico, 91020
        • Investigational Site Number 4845005
  • Poland
      • Krakow, Poland, 31-209
        • Investigational Site Number 6165003
      • Lodz, Poland, 92-213
        • Investigational Site Number 6165002
      • Oswiecim, Poland, 32-600
        • Investigational Site Number 6165004
      • Puławy, Poland, 24-100
        • Investigational Site Number 6165005
      • Rzeszow, Poland, 35-055
        • Investigational Site Number 6165001
  • Romania
      • Bacau, Romania, 600238
        • Investigational Site Number 6425005
      • Bucuresti, Romania, 010825
        • Investigational Site Number 6425002
      • Bucuresti, Romania, 020475
        • Investigational Site Number 6425003
      • Hunedoara, Romania, 331057
        • Investigational Site Number 6425007
      • Lasi, Romania, 700503
        • Investigational Site Number 6425004
      • Targu-Mures, Romania, 540142
        • Investigational Site Number 6425001
  • Russian Federation
      • Chelyabinsk, Russian Federation, 4540
        • Investigational Site Number 6435004
      • Kemerovo, Russian Federation, 650002
        • Investigational Site Number 6435005
      • Krasnodar, Russian Federation, 350032
        • Investigational Site Number 6435003
      • Novosibirsk, Russian Federation, 630091
        • Investigational Site Number 6435006
      • Saint-Petersburg, Russian Federation, 194358
        • Investigational Site Number 6435001
  • South Africa
      • Cape Town, South Africa, 7505
        • Investigational Site Number 7105003
      • Cape Town, South Africa, 7570
        • Investigational Site Number 7105004
      • Johannesburg, South Africa, 2188
        • Investigational Site Number 7105001
      • Pretoria, South Africa, 0002
        • Investigational Site Number 7105002
  • Spain
      • Barcelona, Spain, 08035
        • Investigational Site Number 7245005
      • Barcelona, Spain, 08036
        • Investigational Site Number 7245007
      • Ferrol, Spain, 15405
        • Investigational Site Number 7245003
      • Granada, Spain, 18012
        • Investigational Site Number 7245009
      • Madrid, Spain, 28041
        • Investigational Site Number 7245006
      • Málaga, Spain, 29010
        • Investigational Site Number 7245004
      • Sevilla, Spain, 41009
        • Investigational Site Number 7245001
      • Zaragoza, Spain, 50009
        • Investigational Site Number 7245002
  • Ukraine
      • Chernivtsi, Ukraine, 58022
        • Investigational Site Number 8045004
      • Kiev, Ukraine, 02002
        • Investigational Site Number 8045006
      • Kyiv, Ukraine, 02091
        • Investigational Site Number 8045007
      • Kyiv, Ukraine, 04050
        • Investigational Site Number 8045003
      • Kyiv, Ukraine, 3037
        • Investigational Site Number 8045001
      • Zaporizhzhia, Ukraine, 69600
        • Investigational Site Number 8045002
  • United States
    • Alabama
      • Guntersville, Alabama, United States, 35976-2206
        • Investigational Site Number 8405033
    • Arizona
      • Phoenix, Arizona, United States, 85018-2701
        • Investigational Site Number 8405005
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site Number 8405007
    • California
      • Chula Vista, California, United States, 91910
        • Investigational Site Number 8405015
      • La Jolla, California, United States, 92037
        • Investigational Site Number 8405032
      • Norco, California, United States, 92860-3611
        • Investigational Site Number 8405003
      • Northridge, California, United States, 91324
        • Investigational Site Number 8405013
      • San Dimas, California, United States, 91773
        • Investigational Site Number 8405018
    • Florida
      • Clearwater, Florida, United States, 33761-2022
        • Investigational Site Number 8405021
      • DeLand, Florida, United States, 32720-0834
        • Investigational Site Number 8405001
      • Miami, Florida, United States, 33155-4630
        • Investigational Site Number 8405043
      • Ocoee, Florida, United States, 34761-4547
        • Investigational Site Number 8405006
      • Ormond Beach, Florida, United States, 32174-8187
        • Investigational Site Number 8405025
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Investigational Site Number 8405039
    • Illinois
      • Arlington Heights, Illinois, United States, 60005-4197
        • Investigational Site Number 8405041
    • Indiana
      • Sellersburg, Indiana, United States, 47172-8932
        • Investigational Site Number 8405030
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
        • Investigational Site Number 8405019
    • Michigan
      • Flint, Michigan, United States, 48532-3447
        • Investigational Site Number 8405034
    • Nebraska
      • Norfolk, Nebraska, United States, 68701-2669
        • Investigational Site Number 8405012
    • New York
      • Albany, New York, United States, 12206
        • Investigational Site Number 8405035
      • Bronx, New York, United States, 10455
        • Investigational Site Number 8405014
      • Laurelton, New York, United States, 11413
        • Investigational Site Number 8405027
    • North Carolina
      • New Bern, North Carolina, United States, 28562-5200
        • Investigational Site Number 8405037
      • Winston-Salem, North Carolina, United States, 27103
        • Investigational Site Number 8405038
    • Ohio
      • Dayton, Ohio, United States, 45419-4336
        • Investigational Site Number 8405009
    • Texas
      • Beaumont, Texas, United States, 77702
        • Investigational Site Number 8405004
      • Dallas, Texas, United States, 75208
        • Investigational Site Number 8405036
      • Houston, Texas, United States, 77058
        • Investigational Site Number 8405020
      • Houston, Texas, United States, 77099-4307
        • Investigational Site Number 8405026
      • Hurst, Texas, United States, 76054
        • Investigational Site Number 8405047
      • San Antonio, Texas, United States, 78215
        • Investigational Site Number 8405031
      • San Antonio, Texas, United States, 78249-2782
        • Investigational Site Number 8405016
    • Utah
      • Layton, Utah, United States, 84041-1200
        • Investigational Site Number 8405008
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Investigational Site Number 8405040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

  • Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 milliliter per minute (mL/min)/1.73 per meter square (m^2).
  • Signed written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

  • At the time of screening, age <18 years.
  • Hemoglobin A1c (HbA1c) <7% or >11%.
  • 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 who are unwilling or unable to be tested for pregnancy during the study.
  • Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
  • Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.
Drug: Placebo
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
Experimental: Sotagliflozin 200 mg
Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.
Drug: Placebo
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
Drug: Sotagliflozin
Sotagliflozin 200 mg, tablet, orally, once daily.
Other Names:
  • SAR439954
Experimental: Sotagliflozin 400 mg
Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.
Drug: Sotagliflozin
Sotagliflozin 200 mg, tablet, orally, once daily.
Other Names:
  • SAR439954

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo
Time Frame: Baseline to Week 26
An analysis of covariance (ANCOVA) model was used for the analysis.
Baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)
Time Frame: Baseline to Week 26
An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
Baseline to Week 26
Percentage of Participants With HbA1c <6.5% at Week 26
Time Frame: Week 26
Week 26
Percentage of Participants With HbA1c <7.0% at Week 26
Time Frame: Week 26
Week 26
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo
Time Frame: Baseline to Week 26
An ANCOVA model was used for the analysis.
Baseline to Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: Baseline to Week 26
An ANCOVA model was used for the analysis.
Baseline to Week 26
Change From Baseline in Body Weight at Week 26
Time Frame: Baseline to Week 26
An ANCOVA model was used for the analysis.
Baseline to Week 26
Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg
Time Frame: Baseline to Week 12
An ANCOVA model was used for the analysis.
Baseline to Week 12
Change From Baseline in SBP at Week 12 for All Participants
Time Frame: Baseline to Week 12
An ANCOVA model was used for the analysis.
Baseline to Week 12
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks
An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).
First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hypoglycemic Events
Time Frame: up to 56.3 weeks
Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].
up to 56.3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2017

Primary Completion (Actual)

May 16, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC15166
  • 2016-004906-32
  • U1111-1190-7589 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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