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    Summary
    EudraCT Number:2006-003138-13
    Sponsor's Protocol Code Number:PDY6797
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-003138-13
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multinational study evaluating the safety and pharmacokinetics of 5 and 10 µg AVE0010 single doses and the efficacy, safety and pharmacokinetics of AVE0010 administered for 5 or 6 weeks, either once or twice daily, following dose escalation from 5 to 30 µg in Japanese and Caucasian type 2 diabetic patients not adequately controlled with sulfonylurea or sulfonylurea and metformin
    A.4.1Sponsor's protocol code numberPDY6797
    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 Sponsorsanofi synthelabo recherche
    B.1.3.4CountryFrance
    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.3.2Product code AVE0010
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 320367-13-3
    D.3.9.2Current sponsor codeAVE0010
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The purpose of this study is to investigate the pharmacodynamic, safety, tolerability and pharmacokinetics (PK) of AVE0010 in Japanese and Caucasian type 2 diabetic patients in the same study and to assess the treatment by ethnicity interaction between the two populations with regard to AVE0010.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    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 assess the effects of individually stepwise increasing QD and BID doses of AVE0010 on the increase in plasma glucose concentration induced by a standardized breakfast test meal at the highest tolerated dose of AVE0010 in type 2 diabetic patients.
    E.2.2Secondary objectives of the trial
    The main secondary objective of the study is to assess the treatment by ethnicity interaction of individually increasing QD and BID doses of AVE0010 on the increase in plasma glucose concentration induced by a standardized breakfast test meal between Japanese and Caucasian type 2 diabetic patients at the highest tolerated doses of AVE0010.
    The other secondary objectives of the study are to assess the effects of individually stepwise increasing QD and BID doses of AVE0010 in Japanese and Caucasian patients on pharmacodynamic, safety, tolerability and pharmacokinetics parameters of AVE0010.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Japanese or Caucasian males or females. Female patients must be post-menopausal (i.e. amenorrhea ≥ 12 consecutive months or else follicle stimulating hormone [FSH] and serum estradiol level within post-menopausal range) or surgically sterile for at least 3 months prior to the time of screening. Japanese patients living outside Japan are defined as: 1) having Japanese nationality; 2) parents are both Japanese; 3) living outside Japan for no longer than 5 years
    · Age 20 – 75 years at the time of screening
    · Type 2 diabetes mellitus diagnosed for at least one year prior to the time of screening as established in the medical history and defined by American Diabetes Association (ADA) criteria [4] [Appendix A]
    · Stable type 2 diabetes mellitus treated either with sulfonylurea alone or sulfonylurea and metformin at a stable dose for at least 3 months prior to the time of screening and no other antidiabetic medications for at least 3 months prior to the screening
    · Body mass index (BMI) ≤ 35 kg/m2 at the time of screening
    · HbA1c ≥ 7.0% and ≤ 10.0% at the time of screening
    · Fasting blood glucose at screening between 108-250 mg/dL [6.0-13.9 mmol/L]
    · Willingness and capability to perform specified self-injections and to otherwise comply with study protocol requirements
    E.4Principal exclusion criteria
    Exclusion criteria related to study methodology or general patients characteristics
    · Type 1 diabetes mellitus
    · Hospitalized patient at screening
    · History of chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease or irritable bowel syndrome
    · History of metabolic acidosis, including diabetic ketoacidosis
    · Hemoglobinopathy or hemolytic anemia
    · History of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization within 6 months prior to the time of screening
    · History of drug or alcohol abuse within 6 months prior to the time of screening
    · Cardiovascular, hepatic, neurologic, endocrine, active malignant tumor or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
    · Presence of any clinically significant abnormality on the ECG performed at the screening visit
    · Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
    · Hypotension at the time of screening with a resting systolic blood pressure < 90 mmHg
    · Renal or hepatic disease at the time of screening,
    - Creatinine: > 1.2 times the upper limit of the normal laboratory range
    - AST, ALT or ALP: > 2 times the upper limit of the normal laboratory range
    - Total bilirubin: > 1.5 times the upper limit of the normal laboratory range
    - Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
    · Any clinically significant abnormality identified on physical examination, laboratory tests or vital signs at the time of screening that in the judgment of the investigator or any subinvestigator would preclude safe completion of the study
    · Blood or plasma donations of more than 400 mL within 1 year or more than 200 mL within 4 weeks prior to the time of screening, or receipt of blood products within 2 months prior to the time of screening
    · Body weight at the time of screening < 45 kg
    · Hemoglobin at the time of screening < 12.5 g/dL
    · Investigator or any subinvestigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol
    · Lack of compliance during the run-in period: more than 3 injections missed
    · Patients living alone or too far from investigational centre
    · Patients considered by the investigator or any subinvestigator as inappropriate for this study for any reason (e.g. impossibility to meet specific protocol requirements, such as scheduled visits and hospitalizations, etc).
    Exclusion criteria related to concomitant medications
    · Use of other oral antidiabetic agents other than sulfonylurea or metformin (e.g., alpha glucosidase inhibitor, buformin, thiazolidinedione or quick acting insulinotropic agent, etc) within 3 months prior to the time of screening.
    · Use of insulin for one week or more within 6 months prior to screening.
    · Use of drugs affecting insulin secretion, except beta blockers (e.g., phenytoin, diazoxide, somatostatin) within 3 months prior to screening
    · Use of systemic glucocorticoids (excluding local application or inhaled forms) for one week or more within 3 months prior to the time of screening
    · Concomitant use of drugs affecting gastrointestinal motility (e.g., including metoclopramide, cisapride, chronic macrolide antibiotics) within 3 months prior to the time of screening. Non-stimulant laxatives are permitted.
    · Likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol (see Section 8.9)
    · Use of any investigational drug within 3 months prior to screening
    · Any previous use of compounds in this investigational drug class, such as Exendin-4 and GLP-1 analogs
    Exclusion criteria related to the sanofi-aventis compound
    · Pregnancy, lactation, women of childbearing potential
    · Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis, within 6 months prior to the time of screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis variable is the change from baseline in the area under the concentration time curve [AUC[0.29h-4:30h](h·mg/dl)] for the postprandial changes in plasma glucose determined after a standardized test breakfast on the last day at the highest well tolerated dose in type 2 diabetic patients.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Phone call 72 hours after the last visit of the last patient, as a post treatment follow up
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 120
    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)
    Patients will stop treatment at last patient last visit then will receive a safety monitoring phone call 72 hours later.
    Patients on placebo will benefit of the same follow up.
    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 Decision2006-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-09-17
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