EUCTR2012-000209-63-HU进行中（未招募）不适用
The efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on GLP-1 receptor agonist and OAD therapy - DUAL™ III - GLP-1 Switch
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
- 429
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
- •- Subjects with type 2 diabetes mellitus
- •- Male or female = 18 years of age
- •- HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- •- Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg OD Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (> 1500 mg or documented maximum tolerated dose) ± stable daily dose of pioglitazone (=30 mg) ±stable daily dose of sulphonylurea (= half of the max approved dose according to local label) =90 days prior to screening visit (Visit 1)
- •- BMI (body mass index) = 40 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 321
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •- Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) = 90 days prior to screening visit (Visit 1)
- •- Use of any drug (except metformin, pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- •- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- •- Screening calcitonin = 50 ng/l
- •- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- •- Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
- •- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion
- •- Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
- •- History of chronic pancreatitis or idiopathic acute pancreatitis
研究者
相似试验
进行中（未招募）
不适用
The efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on GLP-1 receptor agonist and metformin therapyDiabetes Mellitus, Type 2EUCTR2012-000209-63-SKovo Nordisk A/S429
进行中（未招募）
不适用
The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapyDiabetes mellitus, Type 2MedDRA version: 15.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861EUCTR2012-000140-97-DEovo Nordisk A/S429
进行中（未招募）
不适用
The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapyDiabetes mellitus, Type 2MedDRA version: 15.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2012-000140-97-BGovo Nordisk A/S429
已完成
3 期
A trial to investigate the efficacy and safety of insulin degludec/liraglutide in subjects inadequately controlled with sulphonylurea alone or in combination with metformin.CTRI/2012/10/003039ovo Nordisk AS64
招募中
Unknown
Comparison of insulin degludec/liraglutide versus insulin degludec in multiple daily injection therapy on subjects with type 2 diabetes; time to reach target glycemic levelsType 2 diabetesJPRN-UMIN000052156Kushiro Red Cross Hospital30