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    Summary
    EudraCT Number:2009-009320-36
    Sponsor's Protocol Code Number:28431754DIA3009
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-06-23
    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 ConcernedNorway - NOMA
    A.2EudraCT number2009-009320-36
    A.3Full title of the trial
    A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ 28431754 100 mg and JNJ-28431754 300 mg Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy The CANTATA-SU Trial (CANagliflozin Treatment And Trial Analysis - Sulfonylurea)
    A.4.1Sponsor's protocol code number28431754DIA3009
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Cilag International NV
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameCANAGLIFLOZIN
    D.3.2Product code JNJ-28431754
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-28431754
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Glimepiride
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGlimepiride
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGlimepiride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Glimepiride
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGlimepiride
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGlimepiride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Glimepiride
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGlimepiride
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNGlimepiride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 5
    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 nameCANAGLIFLOZIN
    D.3.2Product code JNJ-28431754
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-28431754
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    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 in this study is to compare the HbA1c-lowering efficacy of JNJ-28431754 100 mg and JNJ-28431754 300 mg with glimepiride after 52 weeks of treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives in this study are:
    From Baseline to Week 52
    • To compare the change in body weight from baseline in each JNJ-28431754 group with the glimepiride group
    • To compare the incidence of hypoglycemia in each JNJ-28431754 group with the glimepiride group
    • To compare the change in systolic and diastolic blood pressure from baseline in each JNJ-28431754 group with the glimepiride group
    • To compare the change in fasting plasma glucose (FPG) from baseline in each JNJ-28431754 group with the glimepiride group
    • To assess the overall safety and tolerability of JNJ-28431754 compared with glimepiride
    At Week 104:
    • To compare the durability of HbA1c-lowering efficacy in each JNJ-28431754 group with the glimepiride group from Week 26 to Week 104
    • To assess the overall safety and tolerability from baseline of JNJ-28431754 compared with glimepiride in subjects with T2DM throughout the study

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential subjects must satisfy all of the following criteria to be eligible to participate in the study:
    Inclusion Criteria for Prescreening and Screening
    • Man or woman with T2DM between 18 and 80 years of age, inclusive,
    – On metformin monotherapy at a stable protocol specified dose* for at least 12 weeks before screening and has an HbA1c of > or =7.0% and < or =9.5% at screening; or
    – On metformin monotherapy at a dose <2,000 mg/day with an HbA1c of > or =7.5% and < or =10.0% at screening and has a Week -2 visit HbA1c of > or =7.0% and < or =9.5%, after at least 10 weeks on a stable protocol-specified dose* of metformin; or
    – On metformin at a stable protocol specified dose in combination with an one other oral non-thiazolidinedione (TZD) AHA with an HbA1c of > or =6.5% and < or =9.0% at screening and has a Week -2 visit HbA1c of > or =7.0% and , or =9.5%, after discontinuing the AHA and on a stable protocol-specified dose* of metformin at least 10 weeks; or
    – On metformin at a dose <2,000 mg/day in combination with an one other oral non-thiazolidinedione (TZD) AHA with an HbA1c of > or =6.5% and o r=9.0% at screening and has a Week -2 visit HbA1c of > or =7.0% and < or =9.5%, after discontinuing the AHA and on a stable protocol-specified dose* of metformin at least 10 weeks (*Protocol-specified dose of metformin: > or =2,000 mg/day [or > or =1,500 mg/day, if unable to tolerate a higher dose].)
    • Body mass index (BMI) > or =22 to < or =45 kg/m2, at screening
    • Women must be:
    – postmenopausal, defined as
     >45 years of age with amenorrhea for at least 18 months, or
     >45 years of age with amenorrhea for 6 to < 18 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL.
    – surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
    – abstinent (at the discretion of the investigator/per local regulations), or
    – if sexually active, be practicing a highly effective method of birth control such as hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), male partner sterilization before subject randomization and must agree to continue to use a highly effective method of birth control throughout the study, as local regulations permit.
    • Women of childbearing potential must have a negative urine Beta human chorionic gonadotropin (Beta hCG) pregnancy test at screening and baseline (predose, Day 1).
    • Willing/able to adhere to the prohibitions and restrictions specified in this protocol
    • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    • To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
    Inclusion Criteria for Randomization
    • Subjects must have a HbA1c between (> or =7.0% and (< or =9.5% at Week 2
    • Subjects must have a FPG < or =270 mg/dL (15 mmol/L) at Week-2 (At the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Week -2 criteria may return to the investigational site within 7 days for a one-time repeat FPG and continue in the study if the subject’s repeat FPG meets the criteria.)
    • Fingerstick glucose of >110 mg/dL (6 mmol/L) and <270 mg/dL (15 mmol/L) on Day 1 (At the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Day 1 criteria may return to the investigational site within 7 days for a one-time repeat fingerstick glucose and continue in the study if the subject’s repeat fingerstick glucose meets the criteria.)
    Note: The site should complete the fingerstick glucose determinations at Day 1 before conducting other visit procedures.
    • Subjects must have completed at least 50% or more of their SMBG measurements and diary entries to be considered eligible for randomization.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from participating in the study:
    Metabolic
    • History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
    • History of proliferative diabetic retinopathy for which further evaluation or treatment is planned during the course of the study
    • History of >1 severe hypoglycemic episodes, defined as an episode that requires the help of another person, within 6 months before screening. Refer to Attachment 2, Hypoglycemia: Definitions, Symptoms, and Treatment for a definition of severe hypoglycemia.
    • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
    • Ongoing, uncontrolled, untreated thyroid disorder (ie, the subject has a known thyroid stimulating hormone [TSH] value that is undetectable or >10 mIU/L). Subjects taking a thyroxine supplementation for thyroid disorder should be on a stable dose for (> or =3 months
    • History of an ongoing eating disorder or significant weight loss or weight gain, defined as an increase or decrease of 5% in body weight (based on subject report) within 3 months before screening
    Renal/Cardiovascular
    • Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
    • History of myocardial infarction, unstable angina, or cerebrovascular accident within 3 months before screening, or history of New York Heart Association (NYHA) Class III-IV cardiac disease; Refer to Attachment 3, New York Heart Association Classification of Cardiac Disease, for a description of the classes
    Gastrointestinal
    • Ongoing clinically relevant liver disease (eg, hepatitis B or hepatitis C)
    • History of prior bariatric surgical procedures
    Laboratory
    • Serum creatinine (> or =1.4 mg/dL (124 micromol/L) for men and (> or =1.3 mg/dL (115 micromol/L) for women; or estimated glomerular filtration rate (eGFR) <60 mL/min. Note: a one-time repeat measurement of creatinine may be performed, at the discretion of the investigator.
    • Serum triglycerides (> or =600 mg/dL (6.74 mmol/L) at screening. A one-time repeat of the serum triglycerides is allowed, at the discretion of the investigator.
    • Alanine aminotransferase (ALT) >2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 xULN, at screening, unless in the opinion of the investigator and as agreed upon by the sponsor’s medical officer, the findings are consistent with Gilbert’s disease. A one-time repeat is allowed, at the discretion of the investigator.
    Other conditions
    • History of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinomas in situ)
    • History of human immunodeficiency virus (HIV) infection
    • Any condition that in the opinion of the investigator would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements (eg., planned inpatient surgery or procedures)
    Medications/Therapies
    • Current use of a disallowed therapy (refer to Attachment 4, List of Disallowed Therapies for a complete listing of excluded medications and therapies). Known allergies, hypersensitivity, or intolerance to JNJ-28431754 or its excipients (refer to Section 14.1, Physical Description of Study Drug(s)
    • Contraindication to the use of glimepiride or metformin, as per the local prescribing information, or suspected hypersensitivity to either medication
    • Have taken TZD therapy in the past 16 weeks before screening
    • Received an active investigational drug (including vaccines) or used an investigational medical device within 3 months before the planned start of treatment or received at least one dose of JNJ-28431754 in a prior study
    General
    • History of illicit drug or alcohol abuse within 12 months before screening
    • Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
    • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change in HbA1c from baseline through Week 52.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Glimepiride
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the trial is the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 378
    F.4.2.2In the whole clinical trial 1281
    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)
    Plans for treatment or care after the subject has ended his/her participation in this trial is not different from the standard of care for this condition.
    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 Decision2009-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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