NL-OMON50158已完成2 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 - D5670C00022
Astra Zeneca0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written Informed Consent and willing and able to adhere to all protocol
- •requirements
- •2. Male or female at least 18 years old
- •3. patient with body mass index of at least 27kg/m² and up to 40 kg/m²
- •4. patient with a diagnosis of T2DM on metformin monotherapy
- •5. patient with a glycated haemoglobin of maximum 8.0%
- •6. Female subjects must not be pregnant and lactating females will be excluded
- •7. Females of childbearing potential should be using appropriate contraception
- •For a complete list refer to page 32-33 of the protocol
排除标准
- •1. History / 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.
- •2. Any subject who has received another investigational product or a GLP-1
- •analogue-containing preparation within the last 30 days or 5half-lives of the
- •3.Any subject who has received any of the following medications within the
- •specified time frame prior to the start of the study:
- •a. Herbal preparations or drugs licensed for control of body weight or
- •b. Opiates, domperidone, metoclopramide or other drugs known to alter gastric
- •c. Glucagon
- •d. Warfarin
- •4. concurrent participation in another study with investigational product and
- •repear randomistion in this study is prohibited
- •5. Severe allergy/hypersensitivity to any of the proposed study treatments,
- •excipients, C-13 labelled glucose, deuterated water (2H2O), 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% will be considered eligible.
- •15 Unstable angina pectoris, myocardial infarction, transient ischemic attack
- 另有 3 项未显示
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