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    Summary
    EudraCT Number:2009-017136-40
    Sponsor's Protocol Code Number:28431754DIA3004
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-09
    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 ConcernedLatvia - SAM
    A.2EudraCT number2009-017136-40
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
    A.4.1Sponsor's protocol code number28431754DIA3004
    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 - capsule - 100 mg (eq. 100 mg base)
    D.3.2Product code JNJ-28431754
    D.3.4Pharmaceutical form Capsule*
    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 INNCanagliflozin
    D.3.9.1CAS number 842133-18-0
    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.IMP: 2
    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 - capsule - 300 mg (eq. 300 mg base)
    D.3.2Product code JNJ-28431754
    D.3.4Pharmaceutical form Capsule*
    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 INNCanagliflozin
    D.3.9.1CAS number 842133-18-0
    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.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
    D.8 Placebo: 2
    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 with Moderate Renal Impairment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10062237
    E.1.2Term Renal impairment
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In subjects with inadequately-controlled T2DM and moderate renal insufficiency:
    • To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) after 26 weeks of treatment
    • To assess the safety and tolerability of canagliflozin
    E.2.2Secondary objectives of the trial
    After 26 weeks of treatment, to assess the effects of canagliflozin relative to placebo on: Fasting plasma glucose (FPG); Proportion of subjects with an HbA1c<7%; Systolic and diastolic blood pressure; Proportion of subjects receiving rescue therapy and time to rescue therapy; Fasting plasma lipids; Body weight, and Renal function (eGFR and ACR)

    After 52 weeks of treatment, to assess the effect of canagliflozin relative to placebo on: Glycemic control (HbA1c and FPG); Proportion of subjects with HbA1c <7%; Systolic and diastolic blood pressure; Proportion of subjects receiving rescue therapy and time to rescue therapy; Fasting plasma lipids; Body weight; Renal function (eGFR and ACR)

    Over 26 weeks of treatment, to assess exposure-response relationships of canagliflozin using a population pharmacokinetic (PK) approach.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Man or woman with T2DM, age > or =25 years, and either not on an AHA or on any AHA in monotherapy or combination therapy (including oral or non-oral agents).
    • HbA1c > or =7.0% to < or =10.5% at screening and Week -2 visits.
    • On a stable AHA regimen consistent with local prescribing information (ie, local label[s]) for at least 8 weeks (and 12 weeks for PPARgamma agents [eg, rosiglitazone or pioglitazone]) before Week -2.
    Note: a stable dose of insulin is defined as no change in the insulin regimen (ie, type[s] of insulin) and < or =15% change in the average total daily dose of insulin (ie, averaged over 7 days to account for day to day variability, changes < or =15% over the preceding 8 weeks).
    • Have moderate renal impairment, as defined by eGFR values (estimated by the 4 variable MDRD equation) > or =30 and <50 mL/min/1.73 m2 at both the screening and the Week -2 visit, with generally stable renal function, as demonstrated by < or =25% decline in eGFR at Week-2 relative to the screening visit value
    • FPG < or =270 mg/dL (15 mmol/L) at Week -2
    Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Week -2 FPG 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
    • Site fasting fingerstick glucose of > or =110 mg/dL (6.1 mmol/L) and < or =270 mg/dL (15 mmol/L) on Day 1
    Note: 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 criterion. The site should complete the fingerstick glucose determination at Day 1 prior to conducting other visit procedures.
    • 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 at least 6 months and <18 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL, or
    – surgically sterile (have had a hysterectomy, bilateral oophorectomy, or tubal ligation) or otherwise be incapable of pregnancy, or
    – heterosexually active and practicing a highly effective method of birth control, including 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), or male partner sterilization, and consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study, or
    – not heterosexually active.
    – Note: subjects who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study.
    • 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 and 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.
    • Adequate compliance with the run-in period study procedures, including performance of the SMBG measurements (completed at least 3 or more SMBG measurements per week) with appropriate diary entries, and > or =80% compliance (by pill count) with single-blind placebo capsules.
    E.4Principal exclusion criteria
    Diabetes-related or Metabolic
    • History of diabetic ketoacidosis, T1DM, pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
    • Repeated FPG and/or fasting SMBG glucose measurements >270 mg/dL (15 mmol/L) during the pretreatment phase, despite reinforcement of diet and exercise counseling
    • Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
    • History of 1 or more severe hypoglycemic episode within 6 months before screening.
    • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
    • Ongoing, inadequately controlled thyroid disorder
    • Ongoing eating disorder or significant weight loss or weight gain within 12 weeks, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, subject report
    Renal/Cardiovascular
    • Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant
    • Presence of nephrotic syndrome, or inflammatory renal disease
    • Subject is likely to require dialysis or transplantation during participation in the study
    • Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 3 months before screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease
    • Findings on 12-lead ECG that would require urgent diagnostic evaluation or intervention
    • Uncontrolled hypertension at Week -2
    Gastrointestinal
    • History of hepatitis B surface antigen or hepatitis C antibody positive (unless associated with documented persistently stable/normal range aspartate aminotransferase [AST] and ALT levels), or other clinically active liver disease
    • History of prior bariatric surgical procedure within 3 years before the screening visit
    Laboratory
    • Fasting serum triglycerides > or =600 mg/dL (6.74 mmol/L) at screening (or subsequent visit if not fasting at screening)
    • Alanine aminotransferase level >2.0 times the ULN or total bilirubin >1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor’s medical officer, the elevation in bilirubin is consistent with Gilbert’s disease, the subject may participate)
    • Hemoglobin concentration <10 g/L at screening
    Other conditions
    • History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor’s medical monitor, is considered cured with minimal risk of recurrence)
    • Clinically important hematologic disorder
    • History of human immunodeficiency virus (HIV) antibody positive
    • Investigator’s assessment that the subject’s life expectancy is less than 1 year
    • Any condition that in the opinion of the investigator would make participation not in the best interest of the subject, or could prevent, limit, or confound the protocol specified assessments
    • Major surgery (ie, requiring general anesthesia) within 12 weeks before screening, or subject has not fully recovered from surgery, or planned surgery during time the subject is expected to participate in the study
    Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate
    Medications/Therapies
    • Current use of a disallowed therapy:
    – Any other SGLT2 inhibitor
    – Colesevelam and bromocriptine
    • Subjects receiving anti-hypertensive or anti-hyperlipidemic therapy not on a stable regimen (same medication and dose[s]) for at least 4 weeks before Day 1
    • Known allergies, hypersensitivity, or intolerance to canagliflozin or its excipients (refer to Section 14.1 in protocol, Physical Description of Study Drugs)
    • Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication (for longer than 2 weeks in duration) or an immunosuppressive agent
    Note: subjects using inhaled, intranasal, intra-articular, or topical corticosteroids, or corticosteroids in therapeutic replacement doses may participate
    • Subject currently treated with or who are likely to require treatment with a non steroidal anti-inflammatory drug (NSAID) in higher doses during their expected participation in the study
    • Received an investigational drug (including vaccines), other than a placebo agent, or used an investigational medical device within 3 months before the planned start of treatment or received at least 1 dose of canagliflozin in a prior study
    General
    • History of drug or alcohol abuse within 3 years before screening
    • Pregnant or breast-feeding or planning to become pregnant or breast-feed during the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the change in HbA1c from baseline through Week 26.
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days26
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 83
    F.4.2.2In the whole clinical trial 240
    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 the trial is no different from the standard of care.
    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 Decision2010-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-02
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