CTRI/2017/07/008990已完成3 期
"This is a 26-week, confirmatory, randomised, double-blind, placebo-controlled, multicentre,multinational, two-arm, parallel-group trial, investigating the effect and safety of adding liraglutide1.8 mg/day to pre-trial treatment with any SGLT2 inhibitor (as monotherapy or in combination withmetformin) in subjects with T2DM who have not achieved adequate glycaemic control despitestable treatment with SGLT2 inhibitor ± metformin for at least 90 days prior to trial participation. "
Novo Nordisk India Private Ltd9 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2017年7月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 9
- 主要终点
- To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin on glycaemic control in subjects with type 2 diabetes mellitus.
研究概览
简要总结
| This is a 26-week, confirmatory, randomised, double-blind, placebo-controlled, multicentre, |
| multinational, two-arm, parallel-group trial, investigating the effect and safety of adding liraglutide |
| 1.8 mg/day to pre-trial treatment with any SGLT2 inhibitor (as monotherapy or in combination with |
| metformin) in subjects with T2DM who have not achieved adequate glycaemic control despite |
| stable treatment with SGLT2 inhibitor ± metformin for at least 90 days prior to trial participation. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 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.
- •Diagnosed with type 2 diabetes mellitus.
- •HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
- •Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (≥ 1500 mg or maximum tolerated dose) for at least 90 days prior to the day of screening.
- •All medications in compliance with current local label.
- •Body mass index greater than 20 kg/m2.".
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Previous participation in this trial.
- •Participation is defined as signed informed consent.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).Brazil: According to resolution 466/12: Regarding exclusion criterion: Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- •For women who expressly declare free of the risk of pregnancy, either by not engaging in sexual activity or by having sexual activity with no birth potential risk, use of contraceptive method will not be mandatory.
- •Receipt of any investigational medicinal product within 90 days before screening.
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening.
- •However, short term insulin treatment for a maximum of 14 days during the 90 days prior to the day of screening is allowed.
- •Any disorder which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
- •History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
- •Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •Family is defined as a first degree relative.
- •History or presence of pancreatitis (acute or chronic).
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60 mL/min/1.73m2 as defined by KDIGO1 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening.
- •Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
- •Inadequately treated blood pressure defined as Grade 3 hypertension or higher (systolic ≥180 mmHg or diastolic ≥110 mmHg) at screening.
结局指标
主要结局
To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin on glycaemic control in subjects with type 2 diabetes mellitus.
时间窗: Change from baseline to week 26
次要结局
- To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ±(metformin in subjects with type 2 diabetes mellitus with regards to:)
研究者
研究点 (9)
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