EUCTR2020-000255-12-DE进行中（未招募）1 期
A Phase 2b, Multicentre, Randomised, Double-blind, Placebo controlled, and Open-label Comparator Study of Cotadutide in Participants Who Have Chronic Kidney Disease with Type 2 Diabetes Mellitus - CKD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
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 = 18 and = 79 years of age at the time of signing the informed consent.
- •2/ Estimated glomerular filtration rate = 20 to < 90 mL/min/1.73 m2 determined at the screening visit or a documented occurrence in their medical history at least 3 months prior to randomisation.
- •3/ Receiving background standard of care treatment for renal disease and/or T2DM and being treated according to locally recognised guidelines, as appropriate.
- •4/ Receiving optimised and stable treatment with an angiotensin-converting-enzyme (ACE) inhibitor or an angiotensin II receptor antagonist for = 3 months at screening at the maximum tolerated dose (MTD) unless contraindicated, not tolerated, or in the opinion of the investigator, not practically available or suitable.
- •5/ Micro- or macroalbuminuria as defined by UACR > 50 mg/g or 5.7 mg/mmol.
- •6/ Diagnosed with T2DM with glucose control managed with any insulin and/or any oral therapy combination
- •7/ Haemoglobin A1c range of 6.5 % to 12.5% (inclusive) at screening
- •8/ Body mass index > 25 kg/m^2 at screening or > 23 kg/m^2 for participants enrolled in Japan
- •9/ Negative pregnancy test at screening (serum only) and randomisation (serum or urine) for female participants of childbearing potential and must not be breastfeeding.
- •10/ Female participants of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study to 5 weeks after the last dose.
- •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 113
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •1/ History or presence of significant medical or psychological conditions, including significant abnormalities in laboratory parameters or vital signs
- •2/ Receiving renal replacement therapy or expected to require it within 6 months of being randomised
- •3/ Renal transplant or on the waiting list for renal transplantation
- •4/ Received a GLP-1 analogue-containing preparation within the last 30 days or 5 half-lives of the drug, if known (whichever is longer), at the time of Visit 2
- •5/ Received any of the following medications within the specified time frame prior to the start of the study (Visit 2):
- •(a) Aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 3 days prior to the start of the run-in period (Visit 2)
- •(b) Paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- •(c) Ascorbic acid (vitamin C) supplements at a total daily dose of greater than 1000 mg and within the last 3 days prior to the start of the run-in period (Visit 2)
- •6/ Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug, if known (whichever is longer)
- •7/ Participants with a known severe allergy/hypersensitivity to any of the proposed study interventions or excipients of the product.
- •8/ Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss) or recent episodes of severe hypoglycaemia in the prior 3 months
- •9/ Type 1 diabetes mellitus (T1DM), history of diabetic ketoacidosis, or clinical suspicion of T1DM (eg, undetectable levels of C peptide and positive tests for antibodies indicative of T1DM)
- •10/ Participants with recent acute or subacute renal function deterioration (eg, participants with large fluctuations of creatinine values documented within the 3 months prior to screening)
- •11/ Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal tract (including weight-reducing surgery and procedures) that may affect gastric emptying or could affect the interpretation of safety and tolerability data
- •12/ History of acute or chronic pancreatitis
- •13/ Significant hepatic disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results:
- •(a)Aspartate transaminase (AST) = 3 × upper limit of normal (ULN)
- •(b)Alanine transaminase (ALT) = 3 × ULN
- •(c)Total bilirubin = 2 × ULN
- •14Poorly controlled hypertension defined as:
- •(a)Systolic blood pressure (SBP) > 160 mm Hg
- •(b)Diastolic blood pressure (DBP) = 90 mm Hg
- •- After 10 minutes of seated rest or semi-supine and confirmed by repeated measurement at screening.
- •- Participants who fail blood pressure screening criteria may be considered for 24-hour ambulatory blood pressure monitoring at the discretion of the investigator. Participants who maintain a mean 24-hour SBP = 160 or DBP < 90 mm Hg 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 participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to u
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