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.
ovo Nordisk India Private Ltd0 个研究点目标入组 31 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
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
入选标准
- •1. 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.
- •2. Male or female, age >= 18 years at the time of signing informed consent.
- •3. Diagnosed with type 2 diabetes mellitus.
- •4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
- •5. 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.
- •6. Body mass index greater than 20 kg/m2.
排除标准
- •1. Known or suspected hypersensitivity to trial product(s) or related products.
- •2. Previous participation in this trial. Participation is defined as signed informed consent.
- •3. 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.
- •4. Receipt of any investigational medicinal product within 90 days before screening.
- •5. 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.
- •6. Any disorder which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or
- •compliance with the protocol.
- •7. History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
- •8. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
- •carcinoma. Family is defined as a first degree relative.
- •9. History or presence of pancreatitis (acute or chronic).
- •10. 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.
- •11. Impaired liver function, defined as ALT >=2.5 times upper normal limit at screening.
- •12. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- •13. Planned coronary, carotid or peripheral artery revascularisation known on the day of
- •14. 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.
- •15. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (systolic
- •>=180 mmHg or diastolic >=110 mmHg) at screening.
研究者
相似试验
进行中（未招募）
1 期
A 6 month safety study comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents.MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2011-002790-28-CZAstraZeneca AB11,700
进行中（未招募）
不适用
A 6 month safety study comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents.MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2011-002790-28-SKAstraZeneca AB11,700
进行中（未招募）
1 期
A 6 month safety study comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents.MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2011-002790-28-SEAstraZeneca AB12,460
进行中（未招募）
1 期
A 6 month safety study comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents.AsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-002790-28-DEAstraZeneca AB11,700
进行中（未招募）
不适用
A 6 month safety study comparing Symbicort with inhaled corticosteroid only in asthmatic adults and adolescents.AsthmaMedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-002790-28-ITASTRAZENECA11,700