EUCTR2006-006092-21-DE进行中（未招募）不适用
Effect on glycaemic control of liraglutide or exenatide added to metformin, sulphonylurea or a combination of both in subjects with type 2 diabetesA 26-week randomised, open-label, active comparator, 2-armed, parallel-group, multi-centre, multi-national trial with a 14 week non-randomised extension period followed by an additional 38-week, non-randomised extension period.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 723
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.Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject)
- •2.Subjects diagnosed with type 2 diabetes and treated with either metformin, sulphonylurea or a combination of both, in a stable treatment regimen for at least 3 months prior to screening on maximally tolerated doses of these therapies, at the discretion of the Investigator (short-term change of metformin or sulphonylurea dose in connection with intercurrent illness within 3 months prior to screening is allowed, at the discretion of the Investigator)
- •3.HbA1c 7.0-11.0% (both inclusive)
- •4.Age 18-80 years, both inclusive (or as allowed according to local labelling for metformin, exenatide and sulphonylurea treatment)
- •5.Body Mass Index (BMI) = 45.0 kg/m2
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous treatment with insulin (except for short-term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator)
- •2.Any previous exposure to liraglutide or exenatide
- •3.Treatment with any hypoglycaemic agent(s) other than metformin or sulphonylurea in a period of 3 months prior to screening
- •4.Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper normal limit (one retest analysed at the central laboratory within a week from receiving laboratory results is permitted with the result of the last sample being the conclusive)
- •5.Impaired renal function defined as serum-creatinine = 135 µmol/L (= 1.5 mg/dL) for males and = 115 µmol/L (= 1.3 mg/dL) for females, or as allowed according to local guidelines for metformin or sulphonylurea use (one retest analysed at the central laboratory within a week from receiving laboratory results is permitted with the result of the last sample being the conclusive)
- •6.Unstable angina, acute coronary event, other significant cardiac event (including history of arrhythmias or conduction delays on ECG), or cerebral stroke within the past 6 months
- •7.History of heart failure (NYHA class IV)
- •8.Known retinopathy or maculopathy requiring acute treatment as judged by the Investigator
- •9.Uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg)
- •10.Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the Investigator’s opinion could interfere with the results of the trial
- •11.Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
- •12.Known or suspected hypersensitivity to any components of the trial products
- •13.Use of any drug (except for metformin or sulphonylurea), which in the Investigator’s opinion could interfere with the glucose level (e.g. systemic corticosteroids)
- •14.Receipt of any other anti-diabetic investigational drug within 3 months prior to screening for this trial, or receipt of any investigational drugs not affecting diabetes within 1 month prior to screening for this trial
- •15.Any contraindications to the relevant background treatment or to exenatide according to the local labelling
- •16.Surgery scheduled for the trial duration period (excluding minor surgical procedures performed in local anaesthesia, as judged by the Investigator)
- •17.Previous participation in the randomised phase of this trial. Re-screening is allowed once within the recruitment period
- •18.Known or suspected abuse of alcohol or narcotics
- •19.Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice [for Germany adequate contraceptive measures are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner]).
- •20.Inability to provide informed consent
- •21.Subjects with medical history of MEN2 or FMTC if total thyroidectomy has not been performed or cannot be ensured (i.e. posterior capsule of the thyroid gland not removed).
研究者
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