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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-023799-21
    Sponsor's Protocol Code Number:H9X-MC-GBDJ
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-09
    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 ConcernedSweden - MPA
    A.2EudraCT number2010-023799-21
    A.3Full title of the trial
    The Effect of Dulaglutide on Major Cardiovascular Events in
    Patients with Type 2 Diabetes: Researching Cardiovascular
    Events with a Weekly INcretin in Diabetes (REWIND)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect the Study Drug has on the Heart in Patients with Type 2 Diabetes.
    A.3.2Name or abbreviated title of the trial where available
    REWIND
    A.4.1Sponsor's protocol code numberH9X-MC-GBDJ
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01394952
    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 SponsorEli Lilly & Company
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Informatin
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.1.1.1Trade name Trulicity
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDulaglutide
    D.3.2Product code LY2189265
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    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 INNLY2189265
    D.3.9.1CAS number 923950-08-7
    D.3.9.2Current sponsor codeLY2189265
    D.3.9.3Other descriptive nameDulaglutide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Cardiovascular events in patients with Type 2 diabetes
    E.1.1.1Medical condition in easily understood language
    Heart conditions in patients with Type 2 diabetes
    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 19.1
    E.1.2Level HLT
    E.1.2Classification code 10012654
    E.1.2Term Diabetic complications cardiovascular
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to test the hypothesis that once-weekly injection of 1.5-mg Dulaglutide reduces the occurrence of the composite primary endpoint of death from CV causes, nonfatal myocardial infarction
    (MI), or nonfatal stroke when added to the glucose-lowering regimen of patients with type 2 diabetes, compared to
    the addition of a once-weekly placebo injection.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objectives are to assess the effects of add-on therapy with 1.5-mg Dulaglutide compared to placebo on the occurence of:
    - the composite microvascular endpoint of diabetic retinopathy requiring laser therapy, vitrectomy, or anti-VEGF therapy, development of clinical proteinuria, a 30% decline in estimated glomerular filtration rate (eGFR), or need for chronic renal replacement therapy
    - hospitalization for unstable angina
    - each component of the composite primary endpoint
    - all cause mortality
    - heart failure (HF) requiring hospitalization or an urgent HF visit

    The prespecified safety objectives are to assess the effects of add-on therapy with 1.5-mg Dulaglutide compared to placebo on the incidence of:
    - acute pancreatitis
    - any cancer (excl. basal and squamous cell skin cancer)
    - medullary thyroid carcinoma (MTC)
    - C-cell hyperplasia
    - discontinuation of study drug for any reason
    - severe hypoglycemia
    - allergic/hypersensitivity reactions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] Men or women with type 2 diabetes based on:
    a) a previous diagnosis of type 2 diabetes; or
    b) newly detected type 2 diabetes based on the American Diabetes Association criteria (ADA 2011) as either two of the following criteria or one of the following criteria that is confirmed on a second day:
    - fasting plasma glucose ≥7.0 mmol/L (126 mg/dL), or
    - 2-hour plasma glucose ≥11.1 mmol/L (200 mg/dL) following a
    75-gram oral glucose load, as described by the World Health
    Organization (WHO 2006), or
    - HbA1c ≥6.5% (≥48 mmol/mol)
    [2] HbA1c value of ≤9.5% (≤81 mmol/mol) at screening
    [3] Are taking:
    a) no glucose-lowering drugs; OR
    b) 1 or 2 classes of oral glucose-lowering drugs; with or without basal insulin daily [as defined below in (d)]; if one of the oral glucose-lowering drugs is a DPP-IV inhibitor, the patient must be willing to stop the DPP-IV inhibitor after eligibility is confirmed; OR
    c) 1 or 2 classes of oral glucose-lowering drugs with a GLP-1 analog; with or without basal insulin daily [as defined below in (d)]; the patient must be willing to stop the GLP-1 analog after eligibility is confirmed; OR
    d) basal insulin daily defined as 1 to 2 injections per day of either glargine, detemir, neutral protamine Hagedorn (NPH), or another approved basal insulin.
    [4] No change in the number or class of glucose-lowering drugs, no change in excess of doubling or halving the dose of these drugs, and if on insulin, no change in the dose of insulin in excess of 20% of the average daily dose, for at least 3 months before screening
    [5] If age ≥50 years and established clinical vascular disease defined as 1 or more of the following:
    - a history of MI
    - a history of ischemic stroke
    - a history of coronary, carotid, or peripheral artery revascularization. If prior coronary artery bypass grafting (CABG), the CABG should have been performed >2 years prior to randomization. If prior carotid or peripheral artery revascularization, the revascularization should have been performed >2 months prior to randomization.
    - hospitalization for unstable angina with ECG changes (new or worsening ST or T wave changes), or myocardial ischemia on imaging, or need for percutaneous coronary intervention (PCI);
    OR
    If age ≥55 years and subclinical vascular disease defined as 1 or more of the following:
    - a history of myocardial ischemia by a stress test or with cardiac imaging, with or without history of exertional angina
    - >50% vascular stenosis with imaging of the coronary, carotid, or lower extremity arteries, with or without claudication history
    - ankle-brachial index <0.9
    - 2 consecutive values or a documented history of persistent eGFR<60 mL/minute/1.73m2
    - a history of hypertension with documented LV hypertrophy on an
    ECG or echocardiogram
    - documented history of persistent microalbuminuria or macroalbuminuria; or 2 consecutive urine samples demonstrating micro- or macroalbuminuria
    OR
    If age ≥60 years and at least 2 or more of the following risk factors for CV outcomes:
    - current tobacco use (any form of tobacco)
    - use of at least 1 approved lipid modifying therapy to treat hypercholesterolemia or a documented untreated low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L (130 mg/dL) within the past 6 months
    - documented treated or untreated high-density lipoprotein cholesterol (HDL-C) <1.0 mmol/L (40 mg/dL) for men and <1.3 mmol/L (50 mg/dL) for women or triglycerides ≥2.3 mmol/L (200 mg/dL) within the past 6 months
    - use of at least 1 blood pressure medication to treat hypertension or untreated systolic blood pressure (SBP) ≥140 mm Hg or diastolic blood pressure (DBP) ≥95 mmHg
    - measured waist-to-hip ratio >1.0 for men and >0.8 for women
    [6] Body mass index ≥23 kg/m2
    [7] Adherence to study drug during the run-in period is 100%
    [8] In the investigator’s opinion, are well-motivated, capable, and willing to selfinject study treatment once weekly, as required for this protocol
    [9] Have given written informed consent to participate in this study in accordance
    with local regulations and Ethical Review Board (ERB) governing the study site
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [1] Uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician.
    [2] Have experienced a severe hypoglycemic episode within 1 year prior to randomization.
    [3] Have experienced an acute coronary or cerebrovascular event within 2 months prior to randomization.
    [4] Are currently planning a coronary, carotid, or peripheral artery revascularization.
    [5] Have known chronic renal failure (defined as a known eGFR <15 mL/minute/1.73m2) or are on chronic dialysis at screening.
    [6] Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (such as bariatric) surgery.
    [7] Have a past history of chronic, acute, or idiopathic pancreatitis or
    signs/symptoms of pancreatitis.
    [8] Have severe hepatic dysfunction such as portal hypertension or cirrhosis, acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine transaminase (ALT) level ≥3.0 times the upper limit of normal (ULN) for the reference range at screening.
    [9] Have a) any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of multiple endocrine neoplasia MEN 2A or 2B syndrome), or
    b) any known self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia. This includes patients with a family history of MEN 2A or 2B whose family history for the syndrome is RET negative. The only exception for this exclusion will be patients whose family members with MEN 2A or 2B have a known RET mutation and the potential patient for the study is negative for that RET mutation.
    [10] Have a calcitonin value ≥20 pg/mL according to the central laboratory measurement at screening.
    [11] Are previous organ transplant recipients or are awaiting an organ transplant (corneal transplants [keratoplasty] are allowed).
    [12] Are taking a weight loss drug (over-the-counter or prescription) and are unwilling or unable to discontinue the drug at the time of screening or are taking pramlintide at the time of screening.
    [13] History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening.
    [14] Females who are pregnant or have a positive pregnancy test at screening, or who have given birth within the past 90 days, or who are breastfeeding.
    [15] Females of childbearing potential (that is, females who are between menarche and less than 1-year past the last menses with an intact uterus) who do not agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Menopause is the absence of menses for ≥1 year and/or surgically or chemically induced.
    [16] Are medically unstable with life expectancy <1 year.
    [17] Are unwilling to permit sites to contact their primary physicians to
    communicate information about the study and the patient’s data.
    [18] In the judgment of the investigator, have any other condition likely to limit protocol compliance or reporting of AEs (for example, conditions such as alcoholism, mental illness, drug dependence, or not having access to a refrigerator to store study drug).
    [19] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or intend to participate in another clinical trial while participating in this study.
    [20] Have previously completed or withdrawn from any study investigating dulaglutide.
    [21] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [22] Are Lilly employees or employees of the CRO involved in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the time to first occurrence (after randomization) of the composite of death from CV causes, nonfatal MI, or nonfatal stroke.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    E.5.2Secondary end point(s)
    Secondary efficacy measures include time (after randomization) to:
    - first occurrence of the composite microvascular endpoint of diabetic retinopathy requiring laser therapy, vitrectomy or anti-VEGF therapy, development of clinical proteinuria, a 30% decline in estimated glomerular filtration rate (eGFR), or need for chronic renal replacement therapy
    - first hospitalization for unstable angina
    - first occurrence of each component of the composite primary endpoint
    - death
    - first occurrence of heart failure (HF) requiring hospitalization or an urgent HF visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    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 No
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    Event driven
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA159
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Germany
    Hungary
    India
    Korea, Democratic People's Republic of
    Latvia
    Lithuania
    Mexico
    New Zealand
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months5
    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: 9600
    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 state420
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 9600
    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)
    After the subject has ended their participation in the trial, they will not receive the study drug. Future care will be discussed with the subject and they will continue with their routine care at the discretion of the treating physician.
    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 Decision2011-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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