EUCTR2018-001220-19-GB进行中（未招募）1 期
An Exploratory Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Subjects with Type 2 Diabetes Mellitus
MedImmune Limited, a wholly owned subsidiary of AstraZeneca0 个研究点目标入组 28 人开始时间: 2018年6月12日最近更新:
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
- 28
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 Subjects aged = 30 and = 75 years at screening
- •2 Provision of signed and dated written informed consent (except for consent for genetic and non-genetic research and additional optional assessments) prior to any protocol-related procedures
- •3 Body Mass Index > 28 and = 40 kg/mˆ2 at screening
- •4 Glycated haemoglobin (HbA1c) = 8.0% at screening
- •5 Diagnosed with T2DM with glucose control managed with metformin, with or without a DPPIV inhibitor, SGLT2i, sulfonylurea, or glitinide, where no significant dose change (increase or decrease > 50%) has occurred in the 3 months prior to screening; if the subject is on dual therapy, a 4-week washout of the non-metformin therapy (DPPIV inhibitor, SGLT2i, sulfonylurea or glitinide) will be required prior to Visit 4
- •6 Female subjects of childbearing potential must have a negative pregnancy test at screening and randomisation, and must not be lactating
- •7 Female subjects of childbearing potential who are sexually active with a non-sterilised male partner must be using at least one highly effective method of contraception from screening and must agree to continue using such precautions up until 4 weeks after the last dose of investigational product
- •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 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1 History of, or any existing condition(s) 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 with a cardiac pacemaker or implanted/portable electronic device
- •3 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 (Visit 1)
- •4 Any subject who has received any of the following medications within the specified time frame prior to Visit 2: herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion, naltrexone, phentermine-topiramate, phentermine, lorcaserin, opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying)
- •5 Concurrent participation in another study with an investigational product and prior randomisation in this study is prohibited
- •6 Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, or standardised meals
- •7 Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening
- •8 Abnormal thyroid stimulating hormone (TSH) level of < 0.03 mIU/L or > 10 mIU/L confirmed on two consecutive tests
- •9 Regularly engage in high intensity exercise at least three times per week or have done so in the prior three months
- •10 Clinically 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
- •11 Acute or chronic pancreatitis with or without amylase > 1000 IU/L and/or lipase > 600 IU/L at screening
- •12 Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:
- •(a) Aspartate transaminase (AST) = 3 × upper limit of normal (ULN)
- •(b) Alanine transaminase (ALT) = 3 × ULN
- •(c) Total bilirubin = 2 × ULN
- •13 Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 45 mL/minute/1.73 mˆ2 at screening (GFR estimated according to the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or the Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation isotope dilution mass spectrometry-traceable [SI units])
- •14 Poorly controlled hypertension defined as:
- •(a)Systolic BP > 180 mm Hg
- •(b)Diastolic BP or > 100 mm Hg
- •After 10 minutes of supine rest and confirmed by repeated measurement at screening. Subjects who fail BP screening criteria may be considered for 24-hour ambulatory blood pressure monitoring at the discretion of the investigator. Subjects who maintain a mean 24-hour BP = 180/100 mmHg with a preserved nocturnal dip of > 15% will be considered eligible
- •15 Unstable angina pectoris, myocardial infarction, transient ischemic attack or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coro
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