EUCTR2017-005081-22-GB进行中（未招募）1 期
An Exploratory Phase 2, Randomised, Double-blind, Placebo-controlled, and Open-label Active Comparator Study to Evaluate the Effect of MEDI0382 on Hepatic Glycogen Metabolism 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 51 人开始时间: 2019年10月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
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. Male and female subjects aged = 18 years at screening
- •2. Provision of signed and dated written informed consent (except for consent for genetic research and stool sample microbiome research) prior to any study-specific procedures
- •3. Body mass index (BMI) = 27 and = 40 kg/m2 at screening
- •4. Glycated haemoglobin (HbA1c) = 8.0% 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. Female subjects of childbearing potential must have a negative pregnancy test at screening (serum only) and randomisation (serum or urine), 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 up to 4 weeks after the last dose of investigational product. A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly (see Section 10.2 for definition of females of childbearing potential and for a description of highly effective methods of contraception).
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •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. Specific examples include: dislike/unable to eat any of the standardised meals that will be used during the study and poor venous access.
- •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 as detailed in Section 4.7.2 .
- •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
- •4. Concurrent participation in another study with an investigational product and repeat randomisation in this study is prohibited; subjects randomised into Part A of the study may not be randomised into Part B of the study
- •5. Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, C-13 labelled glucose, deuterated water (2H20), or ingredients of standardised meals
- •6. Any contraindication to magnetic resonance imaging/MRS scanning including claustrophobia or dislike of confined spaces
- •7. 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
- •8. Recurrent unexplained hypoglycaemic episodes (defined as glucose < 3.0 mmol/L or < 54 mg/dL on more than 2 occasions in 6 months prior to screening)
- •9. 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
- •10. Acute or chronic pancreatitis
- •11. Significant hepatic disease (except for NASH or nonalcoholic fatty liver disease 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
- •12. Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73m2 at screening (glomerular filtration rate estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable (International System of Units [SI] units)
- •13. Poorly controlled hypertension defined as:
- •Systolic blood pressure (BP) > 180 mm Hg
- •Diastolic BP > 105 mm Hg
- •14. 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 = 180/105 mm Hg with a preserved nocturnal dip of > 15%
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