Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-001804-43
    Sponsor's Protocol Code Number:EFC14868
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-09-26
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2016-001804-43
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)
    Randomizované, dvojito zaslepené, placebom kontrolované, 52-týždňové, multicentrické klinické skúšanie s paralelnými skupinami na zhodnotenie účinnosti a bezpečnosti sotagliflozínu u pacientov s diabetes mellitus 2. typu, ktorí majú nedostatočnú kontrolu glykémie pri podávaní samotného bazálneho inzulínu, alebo ako prídavnej liečby k perorálnym antidiabetikám (OAD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Sotagliflozin versus Placebo in Subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control while Taking Insulin Alone or with Other Oral Antidiabetic Agents
    A.3.2Name or abbreviated title of the trial where available
    SOTA-INS
    A.4.1Sponsor's protocol code numberEFC14868
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1190-7567
    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 pointExecutive Director, Clinical Ops
    B.5.3 Address:
    B.5.3.1Street Address8800 Technology Forest Place
    B.5.3.2Town/ cityThe Woodlands,Texas,
    B.5.3.3Post code77381-1160
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12818633000
    B.5.5Fax number+12818638088
    B.5.6E-mailmedical-information@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 nameSotagliflozin
    D.3.2Product code SAR439954
    D.3.4Pharmaceutical form 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 INNSOTAGLIFLOZIN
    D.3.9.1CAS number 1018899-04-1
    D.3.9.2Current sponsor codeSAR439954
    D.3.9.3Other descriptive nameLX4211, LX-4211, LP-802034
    D.3.9.4EV Substance CodeSUB179285
    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 placeboTablet
    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 2 diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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
    To demonstrate the superiority of sotagliflozin dose 1 versus placebo with respect to HbA1c (glycosylated hemoglobin) reduction in patients with T2D (type 2 diabetes mellitus) who have inadequate glycemic control on basal insulin alone or with OADs (oral antidiabetic drugs).
    E.2.2Secondary objectives of the trial
    To assess the effects of sotagliflozin dose 1 versus placebo on Fasting Plasma Glucose (FPG), Systolic Blood Pressure (SBP), and body weight
    To assess the effects of sotagliflozin dose 2 versus placebo on hemoglobin A1c, body weight, SBP, and FPG
    To assess the effects of sotagliflozin dose 1 versus placebo on the proportion of patients with HbA1c <7.0% or HbA1c <6.5%
    To assess the effects of sotagliflozin dose 2 versus placebo on the proportion of patients with HbA1c <7.0% or HbA1c <6.5%
    To evaluate the safety of sotagliflozin doses 1 and 2 versus placebo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CGM (continuous glucose monitoring) substudy
    To compare the effect of sotagliflozin dose 1versus placebo on the percentage of time spent within the range of 70-180 mg/dL (3.9 -10 mmol/L) over 24 hours
    (Please refer to the protocol EFC14868)
    E.3Principal inclusion criteria
    - Patients with T2D (Type 2 diabetes) using any types of basal insulin alone or in combination with up to 2 OADs (oral antidiabetic drugs)
    - Patient has given written informed consent to participate in the study in accordance with local regulations
    E.4Principal exclusion criteria
    - At the time of Screening age <18 years or <legal age of majority, whichever is greater
    - Type 1 diabetes mellitus
    - Oral antidiabetic drugs dose not stable for 8 weeks before Screening
    - Use of basal insulin therapy (eg, insulin glargine, Neutral Protamine Hagedorn [NPH], detemir, or degludec) for less than 6 months before Screening
    - Dose of basal insulin (eg, insulin glargine, NPH, detemir, or degludec) not stable for 8 weeks before Screening (ie, total daily insulin dose increased or decreased by more than 20%)
    - Known unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema that is likely to require laser, surgical treatment during study period
    - Use of injectable diabetes drugs other than basal insulin (eg, insulin glargine, NPH, detemir, or degludec), ie, prandial or rapid-acting insulins, short-acting insulins, GLP -1 receptor agonists, or inhaled prandial insulin (Afrezza) within 8 weeks of Screening
    - Use of a selective SGLT2 inhibitor (eg, canagliflozin, dapagliflozin, or empagliflozin) within 12 months prior to the trial
    - Use of systemic glucocorticoids (excluding topical, intra articular, or ophthalmic application, nasal spray or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit
    - Patients with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease that, according to the Investigator, 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
    - Known presence of factors that interfere with the Central Lab HbA1c measurement (eg, genetic Hb variants) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (eg, blood transfusion or severe blood loss in the last 3 months prior to randomization, any condition that shortens erythrocyte survival)
    - Patient who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half lives from prior to Screening, whichever is longer
    - Patients unwilling to perform SMBG (self monitoring of blood glucose), complete the patient diary or comply with study visits and other study procedures as required per protocol
    - Hemoglobin A1c (HbA1c) <7.5% or HbA1c >10.5% measured by the central laboratory at Screening
    - HbA1c <7% measured by the central laboratory at Visit 5 (Week -1)
    - History of diabetic ketoacidosis or nonketotic hyperosmolar coma within 12 weeks prior to the Screening Visit
    - Pregnant (confirmed by serum pregnancy test at Screening) or breastfeeding women
    - Women of childbearing potential 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
    - Mean of 3 separate BP measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure [DBP])
    - History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the Screening Visit
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range
    - Total bilirubin >1.5 times the upper limit of the normal laboratory range (except in case of Gilbert's syndrome)
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change from baseline in hemoglobin A1c (HbA1c )(for sotagliflozin dose 1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 18
    E.5.2Secondary end point(s)
    1- Absolute change from baseline in FPG (for sotagliflozin dose 1)
    2- Absolute change from baseline in SBP for patients with baseline SBP≥130 mmHg (for sotagliflozin dose 1)
    3- Absolute change from baseline in SBP for all patients (for sotagliflozin dose 1)
    4- Absolute change from baseline in BW (for sotagliflozin dose 1)
    5- Percentage of patients with HbA1c <7.0% (for sotagliflozin dose 1)
    6- Percentage of patients with HbA1c <6.5% (for sotagliflozin dose 1)
    7- Absolute change from baseline in HbA1c (for sotagliflozin dose 2)
    8- Absolute change from Baseline in FPG (for sotagliflozin dose 2)
    9- Change in SBP for patients with baseline ≥130 mmHg (for sotagliflozin dose 2)
    10- Absolute change from baseline in BW (for sotagliflozin dose 2)
    11- Percentage of patients with HbA1c <7.0% (for sotagliflozin dose 2)
    12- Percentage of patients with HbA1c <6.5% (for sotagliflozin dose 2)
    13- Proportion of patients with adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4-5-6-7-8-10-11-12- Baseline to week 18
    2-3-9- Baseline to week 12
    13- Up to week 54
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient Reported outcomes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Bulgaria
    Canada
    Czech Republic
    France
    Hungary
    Slovakia
    United Kingdom
    United States
    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
    Last Subject Last Visist (LSLV)
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 640
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 state79
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 560
    F.4.2.2In the whole clinical trial 800
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-09-27
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 22:31:18 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA