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    Summary
    EudraCT Number:2006-006772-38
    Sponsor's Protocol Code Number:R256918OBE2001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-21
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-006772-38
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study to Investigate the Safety and Efficacy of JNJ-16269110 in Overweight and Obese Subjects
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberR256918OBE2001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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, Turnhoutseweg 30, 2340 Beerse, Belgium
    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 nameJNJ-16269110/5-mg/capsules filled with beads
    D.3.2Product code F026
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot Assigned
    D.3.9.1CAS number 403989-79-7
    D.3.9.2Current sponsor codeJNJ-16269110-AAA
    D.3.9.3Other descriptive nameR256918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 nameJNJ-16269110/10-mg/capsules filled with beads
    D.3.2Product code F027
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot Assigned
    D.3.9.1CAS number 403989-79-7
    D.3.9.2Current sponsor codeJNJ-16269110-AAA
    D.3.9.3Other descriptive nameR256918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameJNJ-16269110/15-mg/capsules filled with beads
    D.3.2Product code F028
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot Assigned
    D.3.9.1CAS number 403989-79-7
    D.3.9.2Current sponsor codeJNJ-16269110-AAA
    D.3.9.3Other descriptive nameR256918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    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 the study is to find the appropriate, clinically relevant dosages (among the 5, 10, and 15 mg twice-daily dosages) of JNJ-16269110 by assessing mean changes in body weight from baseline to Week 12, compared to placebo.
    E.2.2Secondary objectives of the trial
    To estimate the dose-response relationship between the different dosages of JNJ-16269110 and the decrease in body weight from baseline to Week 12
    To estimate the effect on weight loss of different JNJ-16269110 dosages versus placebo as expressed by mean percent change from baseline in body weight and in body mass index (BMI), and the percentage of subjects who lose at least 5% or 10% of their initial body weight
    To estimate changes in body composition using anthropometric measurements and by means of Dual X Ray Absorptiometry (DEXA [only at selected sites] to explore if weight loss is predominantly due to loss of fat mass
    To explore changes in obesity-associated comorbidities as assessed by glucose homeostasis, fasting lipid profile, and systolic and diastolic blood pressure
    To explore the effect of JNJ-16269110 on changes in levels of PYY, GLP 1, and oxyntomodulin



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women with a history of T2DM and treated with a stable dose of metformin for at least 2 months prior to screening.

    2. Between 18 and 70 years of age, inclusive

    3. Women must be postmenopausal, defined as having a last menstrual period at least 1 year before screening with a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status;
    or surgically incapable of childbearing (have had a hysterectomy or bilateral oophorectomy or tubal ligation or otherwise incapable of pregnancy);
    or if sexually active, be practicing an effective method of birth control (e.g. spermicide plus barrier, oral contraceptive plus barrier, intrauterine device, or a partner with a vasectomy);
    sexually abstinent.

    4. BMI between 25 and 45 kg/m2, inclusive, measured at screening visit.
    5. HbA1c between 7% and 10%, inclusive, measured at screening visit.
    6. Fasting plasma glucose not exceeding 240 mg/dL (13.3mmol/L) at baseline visit.
    7. Consumption of breakfast and dinner on a daily basis.
    8. Ability to swallow the intact capsule (17.5 mm in length and 9.1 mm in diameter) with water.
    9. Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucometer at home.
    10. Willing to adhere to the prohibitions and restrictions specified in this protocol.

    E.4Principal exclusion criteria
    1. Diabetes other than type 2 diabetes mellitus.
    2. Treatment with oral anti-diabetic agents (other than metformin) or insulin during the 12 weeks before baseline visit.
    3. Prior exposure or known contraindication or hypersensitivity to JNJ 16269110.
    4. History of intolerance to or hypersensitivity to sulfonylurea or sitagliptin.
    5. History of an uninterrupted period of insulin therapy for >1 month period within 1 year prior to baseline visit.
    6. Likelihood of requiring treatment during the study period with anti-diabetic medications such as sulphonylureas, meglitinides, thiazolidinediones, acarbose, dipeptidyl peptidase inhibitors, exenatide and insulins.
    7. Treatment with any investigational drug or devices in the 1 month before baseline visit.
    8. Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to baseline visit, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study.
    9. History of diabetic gastroparesis that is considered to be clinically significant in the opinion of the investigator.
    10. Concurrent use of systemic corticosteroids or intend to be placed on a course of systemic corticosteroids for >1 week during the study.
    11. History or evidence of liver disease, including cirrhosis, or non-alcoholic steatohepatitis/non-alcoholic fatty liver disease.
    12. History of HIV or presence of hepatitis C antibodies or positive hepatitis B serology (refer to Attachment 10, Interpretation of Hepatitis B Results for Enrolling Subjects) at screening.
    13. History of clinically significant gastro-intestinal disease (including but not limited to gluten and non-gluten induced enteropathy, inflammatory bowel disease, malabsorption syndromes).
    14. History of hemoglobinopathy (unreliable HbA1c measurement)
    15. History of major gastro-intestinal surgery other than appendectomy or uncomplicated cholecystectomy.
    16. Pregnancy or nursing or women who plan to become pregnant during the study
    17. History of significant cardiovascular disease, including a history of myocardial infarction (MI), unstable angina and cerebrovascular accident (CVA) within 6 months of enrollment.
    18. History of clinically-significant cardiac valvular disease, significantly, congestive heart failure (cardiovascular disability functional Class III-IV according to the New York Heart Association, see Attachment 6).
    19. 12-lead ECG showing evidence of clinically significant heart rhythm or conduction abnormality at screening or baseline.
    20. An average of 3 seated readings where diastolic blood pressure ³100 mmHg or a systolic blood pressure ³160 mmHg at screening.
    21. Thyroid stimulating hormone (TSH) >1.5 X ULN at enrollment. Subjects on medication for hypothyroidism should have been on a stable dose for at least 3 months before the screening visit.
    22. History of anorexia nervosa, bulimia or binge eating disorder.
    23. Recently (within 3 months from screening) changed smoking habits.
    24. Malignancy or a history of a malignancy within 5 years before Baseline visit, other than basal cell carcinomas of the skin or in situ cervical carcinoma.
    25. History or evidence of clinically significant abnormal values for hematology, coagulation or clinical biochemistry.
    26. Increased liver function tests, if concomitant increase of two or more parameters, including AST, ALT bilirubin, alkaline phosphatase and LDH above 1.5 X ULN and GGT above 2x ULN at screening.
    27. Increased creatinine kinase above ULN in subjects who take lipid lowering agents and CK level above 2 x ULN in subjects who do not take lipid lowering agents at screening visit.
    28. Fasting triglycerides >33.3 mmol/L (600 mg/dL) at screening. One time repeat of the fasting triglycerides is allowed (fasting is defined as no caloric intake for at least 8 hours before the test).
    29. History or evidence of clinically significant abnormal values for hematology, coagulation, or clinical biochemistry, or evidence of renal impairment (serum creatinine >133 mmol/L in men, >124 mmol/L in women).
    30. History of drug or alcohol abuse within the previous 2 years prior to screening visit.
    31. Alcohol consumption exceeding 4 units per day for men or 3 units per day for women; 1 unit is defined as 330 mL beer or 100 mL wine or 30 mL distilled spirits or the equivalent of this.
    32. Receiving any excluded medication, refer to Section 8, Concomitant Therapy.
    33. History of weight-reducing diet or receiving any drugs to treat obesity within the 3 months prior to the baseline visit
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy, safety and tolerability of JNJ-16269110
    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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months5
    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) No
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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 Decision2007-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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