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    Summary
    EudraCT Number:2020-000931-35
    Sponsor's Protocol Code Number:D6470C00005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-25
    Trial 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 number2020-000931-35
    A.3Full title of the trial
    A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults with Type 2 Diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early phase study in patients with Type 2 Diabetes to assess the effect on glucose homeostasis of two dose levels of AZD9567, compared to Prednisolone
    A.4.1Sponsor's protocol code numberD6470C00005
    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 SponsorAstraZeneca AB, 151 85 Södertälje, Sweden
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForskaregatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeS-15 85
    B.5.3.4CountrySweden
    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.3.1Product nameAZD9567 oral suspension
    D.3.2Product code AZD9567 monohydrate
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    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 INNN/A
    D.3.9.1CAS number 1893415-64-9
    D.3.9.2Current sponsor codeAZD9567 monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.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 Prednisolon STADA
    D.2.1.1.2Name of the Marketing Authorisation holderSTADAPHARM GmbH
    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.3.1Product namePrednisolone capsules
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNPrednisolone
    D.3.9.1CAS number 600-90-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboOral suspension
    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 placeboCapsule, hard
    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
    Type 2 Diabetes
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 determine the pharmacodynamic (PD) effect of AZD9567 on glucose homeostasis compared to prednisolone
    E.2.2Secondary objectives of the trial
    • To determine the effect of AZD9567 on continuous glucose monitoring (CGM) compared to prednisolone
    • To determine the PD effect of AZD9567 following a Mixed Meal Tolerance Test (MMTT) compared to prednisolone
    • To determine the PD effect of AZD9567 on glucose homeostasis through an MMTT in comparison to prednisolone
    • To determine the PD effect of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone
    • To determine the effect of AZD9567 on urinary sodium (U-Na) and urinary potassium (U-K) excretion compared to prednisolone
    • To evaluate the PK of AZD9567 following once daily dosing
    • To collect plasma samples for analysis of prednisolone.
    • To explore the relationship between AZD9567 exposure and inhibition of LPS stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2)

    Safety Objective
    • To evaluate the safety and tolerability of AZD9567 in relation to prednisolone
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be aged 18 to 75 years of age inclusive, at the time of Visit 1.

    2. Participants with diagnosis of T2DM for 6 months prior to screening: HbA1c in the diabetes range or fasting blood glucose 126 220 mg/dL.

    3. On stable metformin therapy for at least 4 weeks, where no significant dose change (increase or decrease ≥ 500 mg/day) has occurred prior to screening and HbA1c 6% – 9.5%, or on dual therapy with metformin in combination with SGLT2i or DPP4i and HbA1c 6% – 8%. Participants on dual therapy will require 2 weeks wash-out of SGLT2i or DPP4i.

    4. Venous access suitable for multiple cannulations.

    5. Sex: males and females.
    Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    (a) Male participants: All male participants must be willing to avoid fathering a child by either true abstinence or use (together with their female partner/spouse) a highly effective contraception form of birth control in combination with a barrier method, starting from the time of study intervention administration until 3 months after the Final/ET visit. Acceptable methods of preventing pregnancy are provided below.

    6. Female participants must be not lactating and not of childbearing potential, defined as those who are surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or are postmenopausal (defined as at least 1 year since last menses and having an elevated [> 40 mIU/mL] FSH laboratory value at screening).
    If sexually active, nonsterilized males who have a female partner of childbearing potential must practice two effective contraceptive measures from screening through at least 28 days after the last dose of IMP has been administered. Note: Male condom plus spermicide is only considered an effective contraceptive measure when used together with another method based on following list (none of the listed methods are intended to be used alone). Highly Effective Methods of Contraception include:
    (a) Tubal occlusion
    (b) Copper T intrauterine device
    (c) Levonorgestrel-releasing intrauterine system (eg, Mirena®)
    (d) Medroxyprogesterone injections (eg, Depo-Provera®)
    (e) Etonogestrel implants (eg, Implanon®, Norplan®)
    (f) Combined pills
    (g) Norelgestromin/ethinyl estradiol transdermal system (eg, Ortho Evra®)
    (h) Intravaginal device (eg, NuvaRing®)
    (i) Desogestrel (Cerazette®).

    7. Capable of giving signed informed consent.

    8. Provision of informed consent prior to any study specific procedures.
    E.4Principal exclusion criteria
    1. History or presence of type 1 diabetes.

    2. History of severe hypoglycaemia or hypoglycaemia unawareness within the last 6 months.

    3. History or presence of diabetic foot ulcers.

    4. Participants with advanced diabetic complications (eg, symptomatic nephropathy, gastroparesis, proliferative retinopathy, significant atherosclerotic disease, congestive, heart failure etc).

    5. History of clinically significant lactic acidosis or ketoacidosis following diagnosis with T2DM.

    6. History of, or known significant infection or positivity at Visit 1, including hepatitis A, B, or C, HIV, tuberculosis (ie, positive result for interferon-γ release assay, QuantiFERON® TB Gold), that may put the participant at risk during participation in the study.

    7. History and / or presence of COVID-19:
    (a) Participants who have had a severe course of COVID-19 (ie, hospitalisation, extracorporeal membrane oxygenation [ECMO], mechanically ventilated)
    (b) Participants with clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnoea, sore throat, fatigue, or confirmed current infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission to the CRU
    (c) Participants with confirmed COVID-19 infection by PCR test before randomisation.

    8. Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1.

    9. History of or current alcohol or drug abuse (including marijuana), as judged by the investigator.

    10. Previous psychiatric disorders, including but not limited to:
    (a) Participants have been committed to an institution by way of official or judicial order
    (b) Any active psychiatric illness associated with unstable weight control or which would result in inability to comply with study requirements
    (c) History of severe affective disorder including major depressive or maniac-depressive illness
    (d) History of previous steroid psychosis.

    11. Any latent, acute, or chronic infections or at risk of infection, or history of skin abscesses within 90 days prior to the first administration of IMP at the discretion of the investigator.

    12. History of adrenal insufficiency.

    13. History or current inflammatory disorder.

    14. Any other condition that, in the opinion of the investigator, would interfere with evaluations of the IMP or interpretation of participant safety or study results, including, but not limited to:
    (a) History of previous gastric/duodenal ulcers or surgery affecting the upper GI tract likely to affect the interpretation of safety and tolerability data
    (b) History of cholelithiasis leading to episodes of acute cholecystitis not treated by cholecystectomy, or known biliary disease
    (c) History or presence of dyspepsia or oral intolerance to steroids
    (d) History of cancer, with the exception of non-melanoma skin cancer which is considered cured based on investigator assessment
    (e) History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

    15. History of severe allergy/hypersensitivity to AZD9567 or any of the excipients of the product, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.

    16. Oral or parenteral steroids 8 weeks prior to randomisation and during the study. Topical and inhaled steroids 4 weeks prior to randomisation are acceptable.

    17. Use of any prohibited medication during the study or if the required washout time of such medication was not adhered to.

    18. Receipt of live or live attenuated vaccine within 4 weeks prior to the first administration
    of IMP.

    19. Planned in-patient surgery, major dental procedure, or hospitalisation during the study.

    20. Previous participation or prior screen failure in the current study, or participation in any other research study within 1 month prior to Visit 1.

    21. Patient treated with any investigational drug within 30 days (or 5 half-lives, whichever is longer) prior to Visit 1.

    22. Uncontrolled hypertension (BP > 160 mmHg systolic or > 95 mmHg diastolic).

    23. Diagnosis of heart failure and current symptoms regardless of definition, ie, HfpEF, HfrEF.

    24. Acute coronary syndrome / unstable angina, coronary intervention procedures (percutaneous coronary intervention or coronary artery bypass graft) within the past 6 months.

    25. Stroke within the past 3 months.

    26. QTcF > 470 ms or family history of long QT-syndrome.

    27. AV-block II-III or sinus node dysfunction with significant pause, not treated with pacemaker.
    E.5 End points
    E.5.1Primary end point(s)
    Change in glucose AUC(0 4) versus baseline compared to prednisolone following a standardised MMTT
    E.5.1.1Timepoint(s) of evaluation of this end point
    A standardised mixed meal will be administered on day 1 and day 4 in each treatment period.
    Blood samples to be taken 15 mins pre- and 10, 20, 30, 60, 75, 120, 180, 240 min post-mixed meal intake.
    E.5.2Secondary end point(s)
    • Mean daily glucose at 48 – 72 hours treatment as determined from multiple measures via the CGM system
    • Rise in mean daily glucose over 24 hour periods from start of IMP dosing (0 – 24 hours, 24 – 48 hours, 48 – 72 hours)
    • Change from baseline in fasting glucose
    • Change from baseline AUC(0 4) on hormones related to glucose homeostasis (insulin, glucagon, GLP-1, GIP, FFAs)
    • Change from baseline in AUC(0 4) on plasma glucose, insulin, and C-peptide
    • MMTT derived first phase insulin response (ΔI15/ΔG15, ΔI30/ΔG30, ΔC15/ΔG15, ΔC30/ΔG30)
    • HOMA IR, HOMA S, Modified Matsuda index
    • 24-hour urinary sodium and potassium concentration
    • Plasma PK parameters
    • Plasma concentrations of prednisolone
    • TNFα concentrations

    Safety:
    AEs/SAEs, Vital signs, ECGs, Changes in clinical chemistry/haematology parameters, Morning serum cortisol, ACTH

    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to section E.5.2.
    Endpoints related to MMTT see section E.5.1.1.
    Plasma PK: at Day 3 in both treatment periods. Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 h.
    TNFa concentrations: at Day 3 in both treatment periods. Pre-dose, Post dose 1, 2, 4, 8, 12, 24 h.
    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 No
    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 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 Yes
    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.8.2.4Number of treatment arms in the trial6
    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 concerned4
    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 study is defined as the last date reported in the ‘End of Study’ CRF for all participants. Justification: If the last subject dies or withdraws from the study (among other examples), the end of study would not be the last visit but a but a specific event (death, withdrawal).
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial 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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state46
    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)
    There are no plans to provide study treatment after termination of the study.
    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 Decision2020-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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