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    Summary
    EudraCT Number:2006-002902-74
    Sponsor's Protocol Code Number:EML 017008-004
    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:2006-08-28
    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 number2006-002902-74
    A.3Full title of the trial
    A double-blind, double-dummy, randomized, controlled, multi-centre study of the activity and safety of 2 daily doses of EMD 387008 versus placebo and metformin in parallel groups after 8 weeks of treatment in type 2 diabetic subjects.
    A.3.2Name or abbreviated title of the trial where available
    DEEP study
    A.4.1Sponsor's protocol code numberEML 017008-004
    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 SponsorMerck Santé s.a.s.
    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.3.1Product nameEMD 387008
    D.3.2Product code EMD 387008
    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.3.9.1CAS number 775351-61-6
    D.3.9.2Current sponsor codeEMD 387008
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Glucophage 850 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form 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 INNmetformin hydrochloride
    D.3.9.1CAS number 1115-70-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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 placeboTablet
    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
    Phase II study on type 2 diabetic subjects
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the activity of EMD 387008 versus placebo on glycemic parameters in type 2 diabetic subjects after 8 weeks of treatment
    E.2.2Secondary objectives of the trial
    - Assessment of the activity of EMD 387008 versus placebo on non-glycemic parameters in type 2 diabetic subjects after 8 weeks of treatment·
    - Comparison of the effect of EMD 387008 versus metformin on glycemic and non-glycemic parameters in type 2 diabetic subjects after 8 weeks of treatment·
    - Assessment of the tolerability and safety of EMD 387008 versus placebo and metformin in type 2 diabetic subjects after 8 weeks of treatment·
    - Evaluation of pre-dose plasma concentrations of EMD 387008 and metformin during the course of the treatment and pre- and post-dose concentrations after 8 weeks of treatment in type 2 diabetic subjects and correlation with possible efficacy and/or safety·
    - Analysis of polymorphism in OCT-1 and OCT-2 transporters and correlation with both PK parameters and with efficacy and/or safety parameters
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female type 2 diabetic subjects who are not receiving antidiabetic treatment or who are being treated with antidiabetic monotherapy including metformin, sulfonylurea, glinide or acarbose·
    - Age between 18 and 70 years·
    - Body mass index (BMI) >=20 and <40 kg/m²·
    - Fasting plasma glucose >=7.8 mmol/L and <=13.3 mmol/L (>=140 mg/dL and <=240 mg/dL) at Visit 4a·
    - HbA1c <=10%, at screening visit.
    - No treatment with thiazolidinediones or insulin within 3 months before randomization·
    - No treatment with statin or fibrate within 3 months before randomization·
    - Creatinine clearance equal or above 60 mL/[min*1.73 m2] as estimated by the Modification of Diet in Renal Disease (MDRD) formula·
    - Albuminuria of <300 µg/mg creatininuria·
    - No acute cardiovascular event within 3 months before randomization·
    - Effective contraception for women if the risk for conception exists·
    - Subject has given written informed consent before any study-related activities are carried out
    E.4Principal exclusion criteria
    - Any disease which in the investigator’s opinion would exclude the subject from the study·
    - Acute or chronic diseases which can cause severe tissue hypoxia, e.g. cardiac and respiratory insufficiency or acute myocardial infarction·
    - Acute conditions which can impair renal function, e.g. dehydration or severe infections·
    - Uncontrolled high blood pressure [BP] (diastolic BP >100 mmHg or systolic BP >180 mmHg)·
    - History of drug-induced Torsade de Pointes, or presence of a familial long QT syndrome·
    - Impairment of hepatic function (alkaline phosphatase or aspartate aminotransferase [AST], or alanine aminotransferase [ALT] >3 x the upper limit of normal)·
    - Evidence of retinopathy of severity >=35, in the Classification of Retinopathy Severity (Early Treatment Diabetic Retinopathy Study (assessed by an ophthalmologist in the 6 months preceding inclusion)·
    - Pregnancy or lactation·
    - History of any clinically important neurological disorders and/or epilepsy·
    - Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness·
    - Presence of a contraindication to the study medication, including metformin·
    - Known hypersensitivity to any of the constituents or excipients of the study drug and metformin tablets, or history of relevant drug and/or food allergies (e.g. anaphylactic, anaphylactoid reactions)·
    - Change in currently used medication and/or use of any new prescription or non-prescription medication within 14 days prior to randomization. The occasional use of paracetamol is not prohibited·
    - Positive screen for hepatitis B surface antigen (HbsAg), antibody to the hepatitis A virus (anti-HAV; immunoglobulin M [IgM]), antibody to hepatitis C virus (anti-HCV) or antibodies to human immunodeficiency virus (anti-HIV) 1 and 2 at screening·
    - Any history of alcohol abuse or drug addiction·
    - Smoking of more than 10 cigarettes or 3 cigars or 3 pipes per day ·
    - Participation in a clinical study within 60 days before randomization ·
    - Donation of blood within 90 days before randomization
    E.5 End points
    E.5.1Primary end point(s)
    Meal test area under the curve (AUC) glucose with the following time points:
    - before meal test: -0h30, 0h·
    - after meal test: 0h10, 0h20, 0h30, 0h45, 1h, 1h30, 2h, 2h30, 3h, 4h, 5h, 6h
    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 No
    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) 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) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    last visit of last subject
    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 months6
    E.8.9.1In the Member State concerned days
    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 state120
    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 Decision2006-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-23
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