EUCTR2015-005619-33-IT进行中（未招募）1 期
Effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes mellitus treated with basal insulin - Effect and safety of liraglutide 3.0 mg in subjects with overweight or obesity and type 2 diabetes m
OVO NORDISK. S.P.A.0 个研究点目标入组 396 人开始时间: 2021年2月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 396
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
- •- 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
- •- Diagnosed with type 2 diabetes mellitus
- •- Treatment with up to 2 OADs (metformin, glitazone, SGLT-2 inhibitor or sulphonylurea),
- •- Stable treatment with basal insulin according to its label (no requirement of minimum or maximum dose) for at least 90 days prior to screening, as judged by the investigator
- •- HbA1c 6.0-10.0% (both inclusive)
- •- BMI = 27 kg/m2
- •- Age = 18 years at the time of signing informed consent
- •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 326
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •- Diagnosis of type 1 diabetes
- •- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s
- •questionnaire question 8
- •- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
- •- Unable or unwilling to perform self-monitoring of plasma glucose according to the protocol and to keep a diabetes diary
- •- Treatment with any hypoglycaemic medications other than OADs and basal insulin within the past 90 days prior to screening
- •- Treatment with a DPP-IV inhibitor within the past 90 days prior to screening
- •- Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
- •- Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)
- •- 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). For Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
- •- Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- •- History of pancreatitis (acute or chronic)
- •- History of major depressive disorder within the past 2 years
- •- Any lifetime history of a suicide attempt
- •- Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic =180 mmHg or diastolic =110 mmHg).
- •- History of malignancy (except for non-melanoma skin cancer) within the past 5 years
研究者
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