Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

April 16, 2021 updated by: Lexicon Pharmaceuticals

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea Alone or in Combination With Metformin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a Sulfonylurea Alone or With Metformin

Primary Objective:

To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in combination with Metformin.

Secondary Objectives:

  • To compare Sotagliflozin 400 mg versus placebo based on:
  • Change from baseline in fasting plasma glucose (FPG).
  • Change from baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mm Hg).
  • Change from baseline in SBP for all participants.
  • Change from baseline in body weight.
  • Percentage of participants with HbA1c <6.5% and <7.0%.
  • To evaluate the safety of Sotagliflozin 400 mg versus placebo throughout the 79-week trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The duration per participants is up to 85 weeks, including a Screening Period consisting of a Screening phase of up to 2 weeks and a 2-week single-blind Run-in phase, a 26-week double blind Core Treatment Period, a 53 week double blind Extension, and a 2-week post treatment Follow-up period to collect safety information.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
507

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Investigational Site Number 1003003
      • Ruse, Bulgaria, 7002
        • Investigational Site Number 1003002
      • Sofia, Bulgaria, 1784
        • Investigational Site Number 1003004
  • Estonia
      • Parnu, Estonia, 8001
        • Investigational Site Number 2333003
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Investigational Site Number 3483001
      • Budapest, Hungary, 1033
        • Investigational Site Number 3483007
      • Budapest, Hungary, 1036
        • Investigational Site Number 3483008
      • Budapest, Hungary, 1036
        • Investigational Site Number 3483010
      • Budapest, Hungary, 1106
        • Investigational Site Number 3483004
      • Budapest, Hungary, 1213
        • Investigational Site Number 3483006
      • Gyula, Hungary, 5700
        • Investigational Site Number 3483011
      • Hatvan, Hungary, 3000
        • Investigational Site Number 3483009
      • Kecskemet, Hungary, 6000
        • Investigational Site Number 3483005
      • Pécs, Hungary, 7623
        • Investigational Site Number 3483003
      • Zalaegerszeg, Hungary, 8900
        • Investigational Site Number 3483012
  • Korea, Republic of
      • Goyang-Si, Gyeonggi-Do, Korea, Republic of, 10380
        • Investigational Site Number 4103001
      • Guri-Si, Gyeonggi-Do, Korea, Republic of, 11923
        • Investigational Site Number 4103011
      • Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 13620
        • Investigational Site Number 4103003
      • Seoul, Korea, Republic of, 06591
        • Investigational Site Number 4103007
      • Seoul, Korea, Republic of, 1830
        • Investigational Site Number 4103006
      • Seoul, Korea, Republic of, 3722
        • Investigational Site Number 4103010
      • Seoul, Korea, Republic of, 7345
        • Investigational Site Number 4103005
      • Wonju-Si, Gangwon-Do, Korea, Republic of, 26426
        • Investigational Site Number 4103009
  • Poland
      • Gdansk, Poland, 80-382
        • Investigational Site Number 6163005
      • Gdynia, Poland, 81-537
        • Investigational Site Number 6163006
      • Katowice, Poland, 40-040
        • Investigational Site Number 6163003
      • Poznan, Poland, 60702
        • Investigational Site Number 6163002
      • Warszawa, Poland, 01-192
        • Investigational Site Number 6163001
      • Wroclaw, Poland, 50-381
        • Investigational Site Number 6163004
  • Romania
      • Bucuresti, Romania
        • Investigational Site Number 6423004
      • Iasi, Romania, 700732
        • Investigational Site Number 6423002
  • Slovakia
      • Bratislava, Slovakia, 831 06
        • Investigational Site Number 7033006
      • Bratislava, Slovakia, 851 01
        • Investigational Site Number 7033001
      • Bratislava, Slovakia, 851 01
        • Investigational Site Number 7033002
      • Malacky, Slovakia, 901 01
        • Investigational Site Number 7033004
      • Sturovo, Slovakia, 943 01
        • Investigational Site Number 7033003
      • Trencin, Slovakia, 911 01
        • Investigational Site Number 7033007
  • Ukraine
      • Kyiv, Ukraine, 2002
        • Investigational Site Number 8043001
      • Kyiv, Ukraine, 3037
        • Investigational Site Number 8043003
      • Kyiv, Ukraine, 3049
        • Investigational Site Number 8043002
  • United Kingdom
      • Birmingham, United Kingdom, B15 2SQ
        • Investigational Site Number 8263012
      • Cardiff, United Kingdom, CF15 9SS
        • Investigational Site Number 8263009
      • Glasgow, United Kingdom, G20 0SP
        • Investigational Site Number 8263007
      • Hexham, United Kingdom, NE46 1QJ
        • Investigational Site Number 8263008
      • Inverness, United Kingdom, IV2 3JH
        • Investigational Site Number 8263003
      • Liverpool, United Kingdom, L22 0LG
        • Investigational Site Number 8263014
      • Manchester, United Kingdom, M15 6SE
        • Investigational Site Number 8263011
      • Reading, United Kingdom, RG2 0TG
        • Investigational Site Number 8263010
  • United States
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Investigational Site Number 8403003
      • Peoria, Arizona, United States, 85381
        • Investigational Site Number 8403018
    • California
      • Greenbrae, California, United States, 94904
        • Investigational Site Number 8403009
      • Huntington Park, California, United States, 90255
        • Investigational Site Number 8403012
      • Los Angeles, California, United States, 90057
        • Investigational Site Number 8403019
      • Montclair, California, United States, 91763
        • Investigational Site Number 8403034
      • Spring Valley, California, United States, 91978
        • Investigational Site Number 8403016
      • Tustin, California, United States, 92780
        • Investigational Site Number 8403014
    • Colorado
      • Northglenn, Colorado, United States, 80234
        • Investigational Site Number 8403001
    • Florida
      • Bradenton, Florida, United States, 34201
        • Investigational Site Number 8403029
      • New Port Richey, Florida, United States, 34652
        • Investigational Site Number 8403004
      • North Miami Beach, Florida, United States, 33162
        • Investigational Site Number 8403020
      • Ocoee, Florida, United States, 34761
        • Investigational Site Number 8403026
      • Orlando, Florida, United States, 32810
        • Investigational Site Number 8403032
      • Palm Harbor, Florida, United States, 34684
        • Investigational Site Number 8403008
      • Pembroke Pines, Florida, United States, 33026
        • Investigational Site Number 8403006
      • Port Charlotte, Florida, United States, 33952
        • Investigational Site Number 8403013
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Investigational Site Number 8403007
    • Michigan
      • Flint, Michigan, United States, 48532
        • Investigational Site Number 8403011
    • Minnesota
      • Richfield, Minnesota, United States, 55432
        • Investigational Site Number 8403025
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Investigational Site Number 8403021
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Investigational Site Number 8403028
      • Shelby, North Carolina, United States, 28150
        • Investigational Site Number 8403015
    • Pennsylvania
      • Hatboro, Pennsylvania, United States, 19040
        • Investigational Site Number 8403033
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Investigational Site Number 8403030
    • Texas
      • Dallas, Texas, United States, 75230
        • Investigational Site Number 8403002
      • Houston, Texas, United States, 77081
        • Investigational Site Number 8403022
    • Virginia
      • Burke, Virginia, United States, 22015
        • Investigational Site Number 8403005

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 T2D treated with a Sulfonylurea (≥half the maximum recommended dose as per local label or maximum tolerated dose [documented]) as monotherapy or in combination with Metformin (≥1500 mg per day or maximum tolerated dose [documented]) each at a stable dose for at least 12 weeks without a dose adjustment before screening.
  • Signed written informed consent.

Exclusion criteria:

  • At the time of screening, age <18 years or < legal age of majority, whichever is greater.
  • Body Mass Index (BMI) ≤20 or >45 kilograms per meter square (kg/m^2) at Screening.
  • Hemoglobin A1c (HbA1c) <7% or HbA1c >10% via central lab test at screening.
  • Fasting plasma glucose (FPG) >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
  • Women of childbearing potential with no effective contraceptive method.
  • Treated with an antidiabetic pharmacological regimen other than a Sulfonylurea at a stable dose with or without Metformin within 12 weeks preceding the screening visit.
  • Previous insulin use >1 month (at any time, aside from treatment of gestational diabetes).
  • History of prior gastric surgical procedure including gastric banding or inflammatory bowel disease within 3 years before the Screening Visit.
  • History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit.
  • History of severe hypoglycemia within 6 months prior to the Screening visit.
  • Systolic blood pressure (SBP) >180 millimeter per mercury (mmHg) or diastolic blood pressure (DBP) >100 mmHg or history of hypertensive emergency.
  • Aspartate aminotransferase and/or alanine aminotransferase: >3 times the upper limit of the normal laboratory range (ULN).
  • Total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome).
  • Use of systemic glucocorticoids (excluding topical or ophthalmic, application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
  • Pregnancy, breastfeeding.
  • Participants is unwilling to perform self-monitoring of blood glucose (SMBG), and complete the participant's diary as required per protocol.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Sotagliflozin 400 mg
Following a 2-week run-in phase, participants received two Sotagliflozin tablets of 200 mg, orally once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
Drug: Sotagliflozin (SAR439954)

Pharmaceutical form: tablet

Route of administration: oral
PLACEBO_COMPARATOR: Placebo
Following a 2-week run-in period, participants were randomized to matching placebo administered as 2 tablets, once daily, before the first meal of the day plus Metformin and Sulfonylurea as prescribed for up to 26 weeks in the Core Treatment Period. Participants were eligible to continue treatment in the Extension Period. The total treatment duration was planned for up to 79 weeks.
Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral

Drug: Placebo

Pharmaceutical form: tablet

Route of administration: oral

Drug: Sulfonylurea

Pharmaceutical form: tablet

Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26
Time Frame: Baseline to Week 26
Missing data are imputed using the retrieved dropouts imputation method. An analysis of covariance (ANCOVA) model was used for the analysis.
Baseline to Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 Fasting Plasma Glucose (FPG) at Week 26
Time Frame: Baseline to Week 26
Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Baseline to Week 26
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHg
Time Frame: Baseline to Week 12
Missing data are imputed using the washout imputation method under the missing, not at random framework. 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
Missing data are imputed using washout imputation method under the missing not at random framework. An ANCOVA model was used for the analysis.
Baseline to Week 12
Change From Baseline in Body Weight at Week 26
Time Frame: Baseline to Week 26
Missing data are imputed using the retrieved dropouts imputation method. An ANCOVA model was used for the analysis.
Baseline to Week 26

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hypoglycemic Events
Time Frame: Up to 79 weeks in the treatment period
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]. Participants may be reported in more than one category.
Up to 79 weeks in the treatment period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lexicon Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EFC14835
  • 2016-002826-35 (EUDRACT_NUMBER)
  • U1111-1186-2612 (OTHER: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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