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    The EU Clinical Trials Register currently displays   35486   clinical trials with a EudraCT protocol, of which   5827   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-002025-38
    Sponsor's Protocol Code Number:D5670C00011
    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:2017-06-07
    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 number2017-002025-38
    A.3Full title of the trial
    A Phase 2, Randomised, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Different Doses of MEDI0382 in Overweight and Obese Subjects with Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at how safe, well tolerated, and what effect on the body, different doses of study drug MEDI0382 has in patients who are obese and overweight and have type 2 diabetes
    A.4.1Sponsor's protocol code numberD5670C00011
    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.3.8INN - Proposed INN-
    D.3.9.1CAS number 1686108-82-6
    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 Mellitus
    E.1.1.1Medical condition in easily understood language
    High sugar levels in the blood
    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 20.0
    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
    To assess the effects of MEDI0382 titrated up to a dose level of 300 µg on glucose control and body weight versus placebo after 49 days of treatment (Cohort 1 only)
    E.2.2Secondary objectives of the trial
    • To assess the effects of MEDI0382 titrated up to a dose level of 300 µg on additional measures of glucose control and body weight versus placebo after 49 days of treatment (Cohort 1 only)

    • To characterise the safety profile and tolerability of MEDI0382 titrated up to a dose level of 300 µg during dosing and follow-up (Cohorts 1 and 2)

    • To characterise the PK profile and immunogenicity of 50 and 300µg of MEDI0382 (Cohorts 1 and 2)

    • To characterise the effect of 50 µg of MEDI0382 on glucose lowering versus placebo after 7 days (Cohorts 1 and 2)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Samples Obtained for Future Genetic Research or Future Non-Genetic Research

    Subjects will be offered the possibility of participating in optional future genetic exploratory research (“future genetic research”) and optional future non-genetic exploratory research (“future non-genetic research”). After signing consents for future genetic research and future non genetic research, blood samples will be collected in accordance with the entry criteria and study plan. These samples would be used for research on disorders of metabolism or related complications.
    E.3Principal inclusion criteria
    1. Male and female subjects aged ≥ 18 years at screening

    2. Provision of signed and dated written informed consent (with the exception of consent for genetic and non-genetic research) prior to any study specific procedures

    3. BMI between 27 and 40 kg/m2 (inclusive) at screening

    4. HbA1c range of 6.5% to 8.5% (inclusive) at screening

    5. Diagnosed with T2DM with glucose control managed with metformin monotherapy where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred in the 3 months prior to screening

    6. Subjects prescribed oral dual therapy with a dipeptidyl peptidase-4 (DPPIV) inhibitor, sulphonylurea, glitinide, or a sodium-glucose co transporter 2 (SGLT-2) inhibitor in addition to metformin at screening may be eligible to enter the study following a 4-week washout period

    7. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating

    8. Females of childbearing potential who are sexually active with a nonsterilised male partner must use at least one highly effective method of contraception (see Section 10.2 for definition of females of childbearing potential and for a description of highly effective methods of contraception) from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
    E.4Principal exclusion criteria
    1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject’s ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures

    2. Any subject who has received another investigational product as part of a clinical study or a GLP-1 analogue-containing preparation within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening

    3. Any subject who has received any of the following medications within the specified time frame prior to the start of the study (Visit 2) (see Section 4.7.2 for further details):
    ◦ Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion naltrexone, phentermine-topiramate, phentermine, lorcaserin)
    ◦ Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily
    ◦ Paracetamol (acetaminophen) or paracetamol containing preparations at a total daily dose of greater than 3g
    ◦ Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg
    ◦ Opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying

    4. Concurrent participation in another study of any kind and repeat randomisation in this study is prohibited

    5. Severe allergy/hypersensitivity to any of the proposed study treatments,excipients, or ingredients of standardised meals

    6. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening

    7. Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data

    8. Significant hepatic disease (except for non-alcoholic steatohepatitis [NASH] or non alcoholic fatty liver disease [NAFLD]) without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
    ◦ Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN)
    ◦ Alanine transaminase (ALT) ≥ 3 × ULN
    ◦ Total bilirubin ≥ 2 × ULN

    9. Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 60 mL/minute/1.73m2 at screening (GFR estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable [SI units])

    10. Poorly controlled hypertension defined as:
    ◦ Systolic BP > 160 mm Hg
    ◦ Diastolic BP ≥ 95 mm Hg
    after 10 minutes of seated rest and confirmed by repeated measurement at screening. Subjects who fail BP screening criteria may be considered for 24-hour ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour systolic BP ≤ 160 or diastolic BP < 95 mm Hg with a preserved nocturnal dip of > 15% will be considered eligible

    11. Unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA) or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening

    12. Severe congestive heart failure (New York Heart Association Class III or IV)

    13. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia

    14. Haemoglobinopathy, haemolytic anemia, or chronic anaemia (haemoglobin concentration < 11.5 g/dL [115 g/L] for males, < 10.5 g/dL [105 g/L] for females) at screening or any other condition known to interfere with interpretation of HbA1c measurement

    15. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer

    16. Any positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody

    17. History of substance dependence, alcohol abuse, or excessive alcohol intake (defined as an average weekly intake of > 21 alcoholic drinks for men or > 10 alcoholic drinks for women) within 3 years prior to screening, and/or a positive screen for drugs of abuse or alcohol at screening or on admission to the study unit. Subjects who use tricyclic antidepressants or benzodiazepines for an established clinical indication may be permitted to enter the study based upon the judgement of the investigator.

    18. Involvement of any AstraZeneca, MedImmune, contract research organization (CRO), or study site employee or their close relatives

    19. History of acute or chronic pancreatitis or other diseases of the pancreas
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage change in glucose area under the curve (AUC) as measured by a standardised mixed-meal tolerance test (MMTT) from baseline (Day -1) to the end of 49 days of treatment

    • Percentage change in body weight from baseline (Day 1) to the end of 49 days of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Baseline (Day -1) to the end of 49 days of treatment

    • Baseline (Day 1) to the end of 49 days of treatment
    E.5.2Secondary end point(s)
    • Change in glycated haemoglobin (HbA1c) from baseline (Day -1) to the end of 49 days of treatment

    • Change in fasting plasma glucose (Day -1) from baseline to the end of 49 days of treatment

    • Change in body weight (kg) from baseline (Day 1) to the end of 49 days of treatment

    • Proportion of subjects achieving > 5% body weight loss from baseline (Day 1) after 49 days of treatment

    • Measures of safety and tolerability (24 hour heart rate and blood pressure, other vital signs, ECG, laboratory test results, and adverse events [AEs])

    • PK endpoints for 50 µg MEDI0382 after 1, 7, and 14 days of treatment and 300 µg MEDI0382 after 1 and 28 days of treatment; AUC over a dosing duration, maximum observed concentration, time to maximum observed concentration, terminal half-life, trough plasma concentration and accumulation ratio, Cmin [R0]

    • Development of anti-drug antibodies (ADA) and titre (if confirmed positive)

    • Percentage change in glucose AUC as measured by a standardised MMTT from baseline (Day -1) to the end of 7 days of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Baseline (Day -1) to the end of 49 days of treatment

    • Baseline to the end of 49 days of treatment

    • Baseline (Day 1) to the end of 49 days of treatment

    • Baseline (Day 1) after 49 days of treatment

    • Duration of study (refer to protocol schedule of events)

    • After 1, 7, 14 or 28 days of treatment (refer to protocol schedule of events)

    • Refer to protocol schedule of events

    • Baseline (Day -1) to the end of 7 days of treatment
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 trial4
    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 concerned5
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state63
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 63
    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)
    Standard of care
    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 Decision2017-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-23
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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