JPRN-jRCT2080225031已完成1 期
A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Cotadutide in Japanese Obese Subjects With Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
This Phase I study was conducted in obese participants with type 2 diabetes mellitus (T2DM) at 3 sites in Japan between 21 January 2020 and 8 July 2020.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1. Provision of signed and dated written informed consent prior to any mandatory study specific procedures, sampling, and analyses.
- •2. Subject must be 20 to 74 years of age at screening.
- •3. HbA1c range of 6.5% to 8.5% at screening and run-in visit.
- •4. Willing and able to self-inject investigational product for the duration of the study.
- •5. Individuals who are diagnosed with T2DM and have inadequate glycaemic control with diet and exercise.
- •6. Individuals whose current condition at enrolment are drug naive defined as
- •- Never received medical treatment for diabetes (insulin and/or other anti-diabetic agents [oral or injection]) OR
- •- Received medical treatment for diabetes for less than 30 days since diagnosis.Subjects also should not have a history of insulin therapy within 2 weeks of screening (with the exception of insulin therapy during a hospitalization for other causes or use in gestational diabetes) OR
- •- Previously received medical treatment for diabetes but have not been treated within 6 weeks of randomization.
- •7. BMI within the range 25 to 35 kg/m2 at screening.
- •8. Negative pregnancy test for female subjects.
- •9. Female subjects of childbearing potential who are sexually active with a male partner must be willing to use at least one highly effective method of contraception from screening and up to 4 weeks after the last dose of investigational product.
排除标准
- •1. Subjects with any of the following results at screening and run-in visit
- •2. 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 procedure
- •3. Acute pancreatitis at screening or history of chronic pancreatitis or serum triglyceride levels > 11 mmol/L (1000 mg/dL) at screening.
- •4. 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.
- •5. Significant hepatic disease (except for NASH or non-alcoholic fatty liver disease without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening or run-in visit.
- •- Aspartate transaminase (AST) 3 or more x upper limit of normal (ULN)
- •- Alanine transaminase (ALT) 3 or more x ULN
- •- Total bilirubin (TBL) 2 or more x ULN
- •6. Impaired renal function defined as estimated glomerular filtration rate (GFR) < 60 mL/minute/1.73m2 at screening or run-in visit (GFR estimated according to Modification of Diet in Renal Disease [MDRD] using MDRD Study Equation IDMS-traceable [International System of Units (SI)]).
- •7. Poorly controlled hypertension defined as, For age 55 years or less; Systolic BP > 140 mmHg Diastolic BP 90 mmHg or less For age > 55 years; Systolic BP > 150 mmHg Diastolic BP 90 /mmHg or less After 10 minutes of supine rest and confirmed by repeated measurement at screening or run-in visit. Subjects who fail BP screening criteria may be considered for 24-hour or day time ABPM at the discretion of the investigator. Subjects who maintain a mean 24-hour BP < 130/80 mmHg with a preserved nocturnal dip of > 15% or day time BP < 135/85 mmHg will be considered eligib.
- •8. Resting heart rate is 80 bpm or more at screening or run-in visit.
- •9. Any clinically important abnormalities in rhythm, conduction, or morphology of the 12-lead ECG or any abnormalities that may interfere with the interpretation of serial ECG changes, including QTc interval changes at screening, as judged by the investigator.
- •10. Prolonged QT intervals corrected for heart rate using Fridericia's formula (QTcF) > 450 msec, or family history of long QT-segment at screening or run-in visit.
- •11. PR (PQ) interval prolongation (> 220 msec), intermittent second (Wenckebach block while asleep is not exclusive), or third-degree atrioventricular (AV) block, or AV dissociation at screening or run-in visit.
- •12. Persistent or intermittent complete bundle branch block. A QRS duration < 120 msec is acceptable if there is no evidence of ventricular hypertrophy or preexcitation at screening or run-in visit.
- •13. Abnormal findings during the exercise stress test, such as chest pain, dyspnoea, presyncope, arrhytmias, signs of cardiac ischemia on ECG as judged by the investigator.
- •14. History of, unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft or who are due to undergo these procedures at the time of screening.
- •15. Severe congestive heart failure (New York Heart Association Class III or IV
研究者
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