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    Summary
    EudraCT Number:2014-003716-36
    Sponsor's Protocol Code Number:D5670C00002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003716-36
    A.3Full title of the trial
    A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects with a History of Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 and 2 study of multiple increasing doses to evaluate the ability of MEDI0382 to produce the intended result and the safety of effects of MEDI0382 in overweight and obese subjects with Type 2 Diabetes.
    A.4.1Sponsor's protocol code numberD5670C00002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedImmune Limited, a wholly owned subsidiary of AstraZeneca
    B.1.3.4CountryUnited Kingdom
    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 supportMedImmune Limited, a wholly owned subsidiary of AstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune LTD, a wholly owned subsidiary of AstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressMilstein Building, Granta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailinformation.center@astrazeneca.com
    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 MEDI0382
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMEDI0382
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 2 Diabetes in Overweight and Obese Patients
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes in Overweight and Obese Patients
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 effect of MEDI0382 on glucose control and body weight from baseline to the end of a 4-week treatment period at a stable dose (end of treatment).
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1. To assess the effect of MEDI0382 on glucose control as measured by the standardized Mixed Meal Test (MMT), HbA1c, and fructosamine data from baseline through end of treatment
    2. To characterize the safety profile of MEDI0382 following subcutaneous (SC) administration of multiple-ascending doses (MADs)
    3. To characterize the pharmacokinetics (PK) and immunogenicity (IM) of MEDI0382
    4. To characterize the pharmacodynamics (PD) effect of MEDI0382 on glucose metabolism following a MMT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female age 18-65
    -Must provide written informed consent
    -Body mass index 27 to 40 kg/m2
    -Vital signs within normal specified ranges
    -Diagnosis of T2DM and glucose control managed with metformin monotherapy where no significant dose change has occurred in the 3 months prior to screening.
    -Venous access suitable for multiple cannulations.
    -For subjects in Cohort 4, 5 and 6: Willing and able to self-administer daily SC injections.
    -Females must be non-lactating and non-childbearing potential
    -Males must practice 2 effective contraceptive measures if sexually active
    E.4Principal exclusion criteria
    -Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
    -History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
    -History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
    -History or presence of diabetic foot ulcers
    -Any clinically important illness (apart from T2DM for subjects with known diabetes), medical/ surgical procedure, or trauma within 4 weeks prior to Day 1 dosing.
    -Symptoms of insulinopenia or poor blood glucose control
    - Fasting blood glucose ≥ 200 mg/dL
    -Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
    -Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
    -Known or suspected history of alcohol or drug abuse within the past 3 years. Positive drug screen.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints (Cohort 4 only):
    • Change from baseline in glucose AUC (up to 240 minutes post-MMT) to end of treatment
    • Change from baseline in body weight in kg to end of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    • Change from baseline in HbA1c and fructosamine and percent change in 24-hour glucose AUC post-MMT through end of treatment
    • Percent change from baseline in MMT glucose AUC (up to 240 minutes post-MMT) to end of treatment
    • Change from baseline in body weight in kg to end of treatment
    • Adverse events (AEs)
    • Blood Pressure (BP)
    • Pulse
    • Safety laboratory test results
    • ECG findings
    • Columbia-Suicide Severity Rating Scale score (cohort 4)
    • PK endpoints for MEDI0382: AUC over a dosing duration, maximum observed concentration (Cmax), minimum observed concentration, time to maximum observed concentration (Tmax)(all cohorts); terminal half-life, and accumulation ratio (Cohorts 1 to 3 only)
    • Concentration of Metformin
    • Development of antidrug antibody (ADA) and titer (if positive)
    • PD endpoints (glucose metabolism panel):
    ◦ Glucose
    ◦ Beta cell health: insulin, pro-insulin, and c-peptide
    ◦ Incretins: GLP-1, glucagon, gastric inhibitory peptide (GIP)
    ◦ Cohorts 5 and 6 insulin and glucose only
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last study visit- Follow up, 28 days post last study visit.
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned12
    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 No
    E.8.7Trial has a data monitoring committee No
    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 study ("study completion") is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state107
    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)
    None.
    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 Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-02-24
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