CTRI/2018/06/014512进行中（未招募）3 期
Effect and safety of semaglutide 2.4 mg once weekly in subjects with overweight or obesity and type 2 diabetes.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,210
- 试验地点
- 19
- 主要终点
- Change in body weight from baseline
研究概览
简要总结
This is a 68-week, randomised, double-blinded, double dummy, placebo-controlled, multicentre trial. Subjects will be randomised in a 1:1:1 manner to receive either: - Semaglutide s.c. 2.4 mg and semaglutide placebo II once-weekly - Semaglutide s.c. 1.0 mg and semaglutide placebo I once-weekly - Semaglutide placebo I and semaglutide placebo II once-weekly All as an adjunct to a reduced-calorie diet and increased physical activity. There is a 1 week screening period followed by a randomisation visit and a 68-week treatment period. The treatment period is divided into a dose escalation period of 16 weeks and a maintenance period of 52 weeks. Subsequently there is a follow-up period of 7 weeks. The trial population will consist of subjects with BMI > 27 kg/m2 with T2D on 0-3 OADs but not treated with insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities.
- •Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Male or female, age ≥ 18 years at the time of signing informed consent.
- •Body Mass Index (BMI) ≥ 27 kg/m2
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •Diagnosed with T2D ≥ 180 days prior to the day of screening
- •Subject treated with either: i.
- •diet and exercise alone or stable treatment with metformin, SU, SGLT2i, glitazone as single agent therapy or ii.
- •up to 3 OADs (metformin, SU, SGLT2i or glitazone) according to local label
- •HbA1c 7-10% (53-86 mmol/mol) (both inclusive).
排除标准
- •Diabetes Related:
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior day of screening
- •Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this trial, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this trial
- •Treatment with a GLP-1 receptor agonist within 180 days prior to screening
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 30 mL/min/1.73 m2 (< 60 mL/min/1.73 m2 in subjects treated with SGLT2i ) according to CKD-EPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
- •Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation Obesity related:
- •A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device.
- •However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening
- •Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L as measured by central laboratory at screening Mental Health:
- •History of major depressive disorder within 2 years before screening
- •Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- •A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening
- •A lifetime history of a suicidal attempt
- •Suicidal behaviour within 30 days before screening
- •Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening General safety:
- •Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening
- •Presence of acute pancreatitis within the past 180 days prior to the day of screening
- •History or presence of chronic pancreatitis
- •Calcitonin ≥ 100 ng/L as measured by the central laboratory at screening
- •Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- •Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
- •Subject presently classified as being in New York Heart Association (NYHA) Class IV
- •Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator
- •Known or suspected abuse of alcohol or recreational drugs
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Previous participation in this trial.
- •Participation is defined as signed informed consent
- •Other subject(s) from the same household participating in any semaglutide trial
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- •Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol.
结局指标
主要结局
Change in body weight from baseline
时间窗: 68 Weeks
次要结局
- To compare effect of semaglutide s.c. 2.4 mg onceweekly versus semaglutide placebo I/II in achieving weight reduction of ≥ 10% and ≥ 15%.(68 Weeks)
- To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide s.c. 1.0mg once-weekly, on body weight(68 Weeks)
- To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo I/II, on waist circumference(68 weeks)
- To compare the effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo I/II on body weight, BMI,and fasting plasma glucose .(68 Weeks)
- To compare the effect of semaglutide s.c. 1.0 mg once weekly versus semaglutide placebo I/II on HbA1c(68 Weeks)
研究者
研究点 (19)
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