Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : February 24, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date February 24, 2020
Actual Study Start Date  ICMJE November 27, 2017
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
Change in HbA1c [ Time Frame: Baseline to week 26 ]
Absolute change from baseline to week 26 in Hemoglobin A1 (HbA1c)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2017)
  • 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)
  • 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
  • Change in FPG [ Time Frame: Baseline to week 26 ]
    Absolute change in fasting plasma glucose (FPG) from baseline to week 26
  • Change in body weight [ Time Frame: Baseline to week 26 ]
    Absolute change in body weight from baseline to week 26
  • 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
  • Patients with HbA1c <6.5% [ Time Frame: At week 26 ]
    Proportion of patients with Hemoglobin A1c (HbA1c) <6.5% at week 26
  • Patients with HbA1c <7.0% [ Time Frame: At week 26 ]
    Proportion of patients with Hemoglobin A1c (HbA1c) <7.0% at week 26
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Sotagliflozin (SAR439954)

    Pharmaceutical form: tablet

    Route of administration: oral

  • Drug: Empagliflozin

    Pharmaceutical form: capsule

    Route of administration: oral

  • Drug: Placebo

    Pharmaceutical form: tablet

    Route of administration: oral

  • Drug: Placebo

    Pharmaceutical form: capsule

    Route of administration: oral

Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Sotagliflozin (SAR439954)
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Empagliflozin
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
770
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2017)
700
Actual Study Completion Date  ICMJE May 16, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czechia,   France,   Italy,   Latvia,   Mexico,   Russian Federation,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03351478
Other Study ID Numbers  ICMJE EFC14867
2016-001803-22 ( EudraCT Number )
U1111-1190-7607 ( Other Identifier: UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Lexicon Pharmaceuticals
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP