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    Summary
    EudraCT Number:2014-005153-39
    Sponsor's Protocol Code Number:LX4211.1-310-T1DM
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-005153-39
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients with Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control with Insulin Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of adding LX4211 (an investigational oral compound) for patients with Type 1 Diabetes Mellitus (T1D) who have inadequate control of their blood glucose (sugar) levels on insulin alone.

    A.4.1Sponsor's protocol code numberLX4211.1-310-T1DM
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLexicon Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLexicon Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLexicon Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSenior Medical Director
    B.5.3 Address:
    B.5.3.1Street Address8800 Technology Forest Place
    B.5.3.2Town/ cityThe Woodlands
    B.5.3.3Post codeTX 77381-1160
    B.5.3.4CountryUnited States
    B.5.4Telephone number+01 832 702 6527
    B.5.5Fax number+01 832 442 5917
    B.5.6E-mailssawhney@lexpharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLX4211
    D.3.2Product code LX4211
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLX4211
    D.3.9.1CAS number 1018899-04-1
    D.3.9.2Current sponsor codeLX4211
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    High level of sugar (glucose) in the blood
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate superiority of either LX4211 400 mg or 200 mg versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to evaluate the change from Baseline of LX4211 versus placebo in hierarchical order on the following:
    -Proportion of patients with A1C <7.0% and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA)
    -Body weight
    -Bolus insulin dose
    -Fasting plasma glucose (FPG)
    -Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score, and 2-item Diabetes Distress Screening Scale (DDS2) questionnaire score
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Dual-energy X-ray absorptiometry (DEXA) substudy
    The primary objective of the dual-energy X-ray absorptiometry (DEXA) substudy is to compare the effect of LX4211 versus placebo on total fat mass.

    The secondary objectives of the DEXA substudy are to compare the effects of LX4211 versus placebo on the following:
    -Additional fat mass measurements, bone mineral content and bone density
    E.3Principal inclusion criteria
    1) Patient has given written informed consent to participate in the study in accordance with local regulations
    2) Adult patients 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent
    3) Patients are being treated with insulin or insulin analog delivered via CSII or MDI where the method of insulin delivery has not changed from CSII to MDI or vice-versa in the 3 months prior to the Screening Visit
    4) At the Screening Visit, A1C must be 7.0% to 11.0%, inclusive
    5) Must be willing and able to perform SMBG and complete the study diary as required per protocol
    6) Females of childbearing potential must use an adequate method of contraception to avoid pregnancy throughout the duration of the study and for 30 days after the last dose of study drug. Females of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Postmenopause is defined as no menses for ≥12 months without another cause. For females with questionable menopausal history (eg, irregular menstrual periods and age >40 years) a documented serum follicle-stimulating hormone (FSH) level must be ≥30 mIU/mL.
    7) Females of childbearing potential must have a negative serum or urine pregnancy test prior to the start of study drug. In the case of positive urine pregnancy testing, a negative serum sample for pregnancy testing, to confirm that the patient is not pregnant, must be obtained prior to start of study.
    E.4Principal exclusion criteria
    1) Therapies and/or medications
    a) Use of antidiabetic agent other than insulin or insulin analog at the time of screening
    b) Any prior exposure to LX4211
    c) Use of SGLT inhibitors within 8 weeks prior to Screening.
    d) Chronic systemic corticosteroid use, defined as any dose of systemic corticosteroid taken for more than 4 consecutive weeks within the 6 months prior to the Screening Visit.
    2) Diabetes-related conditions:
    a) Type 2 diabetes mellitus, or severely uncontrolled diabetes mellitus as determined by the Investigator
    b) History of severe hypoglycemic event within 1 month prior to the Screening Visit.
    c) History of DKA within 1 month prior to Screening visit, or more than 2 episodes within 6 months prior to the Screening visit
    d) History of nonketotic hyperosmolar state within 6 months prior to the Screening Visit
    3) Laboratory Results
    a) Estimated glomerular filtration rate <45 mL/min/1.73 m2 at Screening, as determined by the 4 variable Modification of Diet in Renal Disease (MDRD) equation
    b) Fasting triglycerides >600 mg/dL.
    c) Abnormal liver function at Screening defined as any of the following: aspartate aminotransferase (AST) >2X upper limit of the normal reference range (ULN), alanine aminotransferase (ALT) >2X ULN, serum total bilirubin (TB) >1.5X ULN.
    d) Screening beta-hydroxy butyrate (BHB) >0.6 mmol/L.
    4) Reproductive status:
    a) Females who are pregnant or breastfeeding or intend to be during the course of the study
    5) Gastrointestinal/hepatic:
    a) By known history, serologic evidence of current infectious liver disease (hepatitis A, B, or C), including antihepatitis A virus (immunoglobulin M), hepatitis B surface antigen, or antihepatitis C virus.
    b) Difficulty swallowing such that the patient cannot take the study drug
    c) History of pancreatitis within 12 months of screening
    6) Renal:
    a) Initiation of chronic dialysis within 30 days prior to the Screening Visit or expected to occur within 180 days after the Screening Visit
    b) Renal disease that required treatment with immunosuppressive therapy, or a history of dialysis or renal transplant
    c) History of hereditary glucose-galactose malabsorption or primary renal glucosuria
    7) Cardiovascular:
    a) New York Heart Association Class III or IV heart failure within 3 months prior to Screening Visit
    b) Hypertensive urgency or emergency within 30 days prior to randomization.
    c) Patients with unstable/symptomatic or life-threatening arrhythmia or heart block.
    d) Patient has had any of the following within 3 months prior to the Screening Visit:
    i. Hospitalization due to unstable angina
    ii. MI
    iii. Coronary artery bypass graft or percutaneous transluminal coronary angioplasty
    iv. Transient ischemic attack or significant cerebrovascular disease
    8) Hematologic:
    a) History of hemoglobinopathies (sickle cell anemia, thalassemia major, sideroblastic anemia) or other disorder that may interfere with A1C determination
    b) Donation or loss of >400 mL of blood or blood product(s) within 8 weeks prior to Screening
    9) Immune system: Known severe immunocompromised status, including, but not limited to, patients who have undergone organ transplantation.
    10) Malignancy or active treatment for malignancy within 5 years prior to the Screening Visit.
    11) Current eating disorder or increase or decrease of weight within the 12 weeks prior to Screening by more than 10%
    12) Known allergies, hypersensitivity, or intolerance to LX4211 or any inactive component of LX4211 or placebo
    13) Administration of any other investigational drug or participation in an interventional clinical research study within 30 days or 5 half-lives (whichever is longer) of planned Screening Visit
    14) History of alcohol or illicit drug abuse within 12 months prior to the Screening Visit
    15) Patient is a study coordinator, employee of an Investigator or Investigator’s site, or immediate family member of any of the aforementioned
    16) Any condition that, in the opinion of the Investigator, may render the patient unable to complete the study
    17) The presence of a clinically significant medical history, physical examination, or laboratory finding that, in the opinion of the Investigator or the Sponsor, may interfere with any aspect of study conduct or interpretation of results.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from Baseline to Week 24 in A1C of either dose of LX4211 (400 mg or 200 mg) treatment group compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are to be measured as change from Baseline in either LX4211 dose compared to placebo for each of the following listed below.

    -Proportion of patients with A1C <7.0% (at Week 24) and no episode of severe hypoglycemia, and no episode of DKA (severe hypoglycemia and DKA occurrence over the cumulative randomized double-blind 24-week Core Treatment Period)
    -Body weight at Week 24 (absolute and percent change)
    -Mean change from Baseline in mean daily bolus insulin dose at Week 24
    -FPG at Week 24
    -Diabetes Treatment Satisfaction as measured by DTSQs scores at Week 24
    -Diabetes Distress as measured by 2-item DDS2 scores at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA102
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Israel
    Italy
    Lithuania
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 375
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 375
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 750
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    T1DM patients are treated with insulin during the trial and will continue on insulin after the end of trial
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-23
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