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    Summary
    EudraCT Number:2007-005881-11
    Sponsor's Protocol Code Number:EFC6015
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2007-005881-11
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top of a sulfonylurea in patients with type 2 diabetes not adequately controlled with sulfonylurea
    A.3.2Name or abbreviated title of the trial where available
    GETGOAL-S
    A.4.1Sponsor's protocol code numberEFC6015
    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-Aventis Recherche&Développement
    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
    Type II Diabetes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term <Manually entered code. Term in E.1.1>
    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 this study is to assess the effects of AVE0010 on glycemic control in comparison to placebo as an add-on treatment to sulfonylurea, without or with metformin, in terms of absolute HbA1c reduction over a period of 24 weeks in patients with type 2 diabetes.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To assess the effects of AVE0010 on:
    − Percentage of patients reaching HbA1c <7% or HbA1c ≤6.5%,
    − Body weight,
    − Fasting plasma glucose,
    − β-cell function assessed by HOMA-β,
    − 2-hour postprandial plasma glucose, glucagon, insulin, proinsulin and C-peptide after a standardized meal challenge test in a substudy in all the patients in selected centers (approximately 30% of all randomized patients),
    • To assess the safety and tolerability of AVE0010,
    • To assess AVE0010 PK and anti-AVE0010 antibody development.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Meal Challenge Test
    Objective: All patients in selected sites leading to approximately 30% of all randomized patients will undergo a standardized meal challenge test to assess fasting and postprandial plasma glucose, glucagon, insulin, proinsulin and C-peptide at V2 (week-1), at Primary endpoint assessment (V12, week 24), at V25 (week 76) and at End of treatment (V70) visit (if End of treatment visit occurs before V25 only).
    E.3Principal inclusion criteria
    Patients meeting all the following inclusion criteria will be screened:
    - Patients with type 2 diabetes mellitus, as defined by WHO (Fasting plasma glucose ≥7 mmol/L (126 mg/dL) or 2 hours postprandial plasma glucose ≥11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year before screening visit, insufficiently controlled with a sulfonylurea alone or with sulfonylurea in association with metformin
    - Written informed consent obtained.
    E.4Principal exclusion criteria
    •Related to study methodo:
    - HbA1c <7.0% or HbA1c >10% at screening
    - At the time of screening age < legal age of majority
    - Women of childbearing potential with no effective contraceptive method (Women of childbearing potential (pre-menopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative serum β-hCG pregnancy test at screening Visit. They must use an effective contraceptive method throughout the study, and agree to repeat serum β-HCG pregnancy test at designated visits)
    - Type 1 diabetes mellitus
    - Sulfonylurea less than the max effective dose according to local labeling
    - Sulfonylurea not at a stable dose for at least 3 months prior to screening
    - In case of treatment with metformin in association with sulfonylurea, no stable treatment with metformin of at least 1.5 g/day (except at least 0.75 g/day in JP and at least 1.0 g/day in KR), for at least 3 months prior to screening visit
    - Fasting Plasma Glucose at screening >250 mg/dL (>13.9 mmol/L)
    - History of hypoglycemia unawareness
    - Body Mass Index (BMI) ≤20 kg/m²
    - Weight change of more than 5 kg during the 3 months preceding the screening visit
    - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
    - History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
    - Hemoglobinopathy or hemolytic anemia, receipt of blood or plasma products within 3 months prior to the time of screening
    - Within the last 6 months prior to screening: History of myocardial infarction, stroke, or heart failure requiring hospitalization
    - Known history of drug or alcohol abuse within 6 months prior to the time of screening
    - Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the proto or interpretation of the study results difficult, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
    - Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >180 mmHg or >95 mmHg, respectively
    - Laboratory findings at the time of screening: AST, ALT or ALP: >2 times the upper limit of the normal laboratory range, Amylase and/or lipase: >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), Hemoglobin <11 g/dL and/or neutrophils < 1500/mm3 and/or platelets <100 000/mm3, 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 sub investigator would preclude safe completion of the study or constrains efficacy assessment
    - Patients considered by the investigator or any sub investigator as inappropriate for this study for any reason (eg, impossibility to meet specific proto requirements, such as scheduled visits, being able to do self-injections, other study staff or relative thereof directly involved in the conduct of the proto...)
    - Patients with condition/concomitant diseases making them non evaluable for the efficacy assessment
    - Use of oral or injectable antidiabetic or hypoglycemic agents other than sulfonylurea and metformin within 3 months prior to the time of screening
    - Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
    - Use of any investigational drug within 3 months prior to screening
    - Pregnancy, lactation
    - Any previous treatment with AVE0010 or participation in a previous study with AVE0010.
    •Related to the background therapy:
    - Renal impairment defined with Creatinine > 1.4 mg/dL in women and Creatinine >1.5 mg/dL in men (applicable only for patients with metformin treatment).
    •Related to AVE0010:
    - End-stage renal disease defined by a serum Creatinine clearance of <15 mL/min and/or patients on dialysis (if no treatment with metformin)
    - Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
    - Allergic reaction to any GLP-1 agonist in the past or to metacresol.
    •Additional Exclusion criteria at the end of the single-blind placebo Run-in phase:
    - Informed consent withdrawal
    - Lack of compliance during the single-blind placebo run-in phase
    - Patient with any adverse event which, by the judgment of the investigator would preclude the inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in HbA1c from baseline to week 24.
    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 No
    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) 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    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 months31
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months31
    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 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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 855
    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 Decision2008-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
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