Protocol H9X-MC-GBGE(a)A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus (AWARD-10: Assessment of Weekly AdministRation of LY2189265 in Diabetes ? 10) - H9X-MC-GBGE(a) AWARD-10

Illy, S.A.0 个研究点目标入组 357 人开始时间: 2015年10月5日最近更新: 2017年3月13日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 357

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•[1]are men or non-pregnant women aged ?18 years at screening
•[2]have T2D
•[3]have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry
•[4]daily doses of all allowed OAMs must have been stable for at least 12 weeks (± 3 days) prior to randomization
•[5]have HbA1c ?7.0% and ?9.5% at study entry
•[6]have body mass index (BMI) ?45 kg/m2 and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight;
•[7]are able and willing to administer once-weekly injections;
•[8]in the investigator?s opinion, are well motivated, capable, and willing to:
•a)perform finger-stick plasma glucose monitoring including scheduled daily PG profile with up to 6 measurements in 1 day;
•b)learn how to self-inject treatment, as required for this protocol
•c) maintain a study diary, as required for this protocol;
•[9]Women of childbearing potential participating must agree to remain abstinent, use 1 highly effective method of contraception (eg, combined oral contraceptive pill and mini-pill, NuvaRing, implantable contraceptives, injectable contraceptives, intrauterine devices or use a combination of 2 effective methods (eg, male condom with spermicide, female condom with spermicide, diaphragm with spermicide, cervical sponge, cervical cap with spermicide) for the entirety of the study. Abstinence or contraception must continue following completion of study drug administration until 4 weeks after the last dose of study drug.
•[10]have given written and informed consent to participate in this study in accordance with local regulations and the Ethical Review board (ERB) governing the study site.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 57

排除标准

•[11]have type 1 diabetes mellitus;
•[12]have been treated with ANY other OAMs (other than SGLT2s and metformin), GLP-1 receptor agonist or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (?14 days) during the 3-month period prior to entry is not exclusionary;
•[13]have any condition that is a contraindication for use of the GLP-1 analog class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization
•[14]for patients using metformin, if a condition that is a contraindication for its use develops between stabilization and randomization;
•[15]discontinue therapy with SGLT2 inhibitors any time prior to randomization and/or metformin, if used, between stabilization and randomization based on the Exclusion Criteria described under [13] and [14] above, or any other reason;
•[16]have a history of ?1 episode of ketoacidosis or hyperosmolar state/coma prior to study entry;
•[17]have a history of hypoglycemia unawareness within the 6 months prior to study entry;
•[18]have been treated with drugs that promote weight loss or have received a diet and/or exercise program with the intent of reducing body weight within 3 months prior to study entry or between study entry and randomization
•[19]are receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) any time between entry and randomization or have received such therapy within 4 weeks prior to study entry;
•[20]have had any of the following cardiovascular (CV) conditions within 2 months prior to study entry: acute myocardial infarction, New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke);
•[21]have a known clinically significant gastric emptying abnormality at study entry, or have undergone bariatric surgery in the past;
•[22]have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; patients with NAFLD are eligible for participation in this trial;
•[23]had chronic or acute pancreatitis any time prior to study entry;
•[24]have an estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in;
•[25]have evidence of a significant, uncontrolled endocrine abnormality at study entry, in the opinion of the investigator;
•[26]have any 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
•[27]have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome);
•[28]have a serum calcitonin ?20 pg/mL as determined by the central laboratory at study entry;
•[29]have evidence of a significant, active autoimmune abnormality (eg, lupus, rheumatoid arthritis) at study entry;
•[30]have a history of transplanted organ (corneal transplants [keratoplasty] are allowed);
•[31]have a history of an active or untreated malignancy,

研究者

发起方

Illy, S.A.

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