NCT03258268已完成不适用
A 26-week, Multicenter, Controlled Trial of the Glycemic Outcomes of Individualized Treatment Support in Patients With Type 2 Diabetes
Läkarexpressen AB3 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2017年8月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 311
- 试验地点
- 3
- 主要终点
- HbA1c
研究概览
简要总结
A 26-week, multicenter, parallel two-arm, randomized controlled trial of the glycemic outcomes of individualized treatment support in patients with type 2 diabetes. The primary objective of the trial is to confirm the superiority of standard of care with EASY DSS versus standard of care without EASY DSS in terms of glycemic control in patients with type 2 diabetes with ongoing treatment with any antidiabetic drug(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A double-blind design is not feasible due to the need for physicians to use respectively not use the EASY DSS.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •≥ 18 years of age at the time of signing informed consent
- •Type 2 diabetes (diagnosed clinically) ≥ 6 months prior to screening
- •HbA1c ≥ 7.0 [58 mmol/mol] by central laboratory analysis
- •Stable daily treatment with any single antidiabetic drug or any combination of antidiabetic drugs for at least 90 days prior to screening (dose adjustment ±10% of insulin dose and temporary dose correction because of e.g. infection are allowed)
排除标准
- •Previous participation in this trial. Participation is defined as informed consent.
- •Currently participating in other clinical trials for diabetes
- •Type 1 diabetes diagnosed clinically and/or by the presence of diabetes-associated autoantibodies
- •History of diabetic ketoacidosis or hyperosmolar hyperglycemic state
- •Corticosteroid-induced or pancreatitis-induced diabetes
- •History of chronic or acute pancreatitis
- •Known or suspected substance abuse
- •Pregnancy
- •Anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids or statins)
- •Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
- •Renal failure stage 5, defined as (estimated or exact) glomerular filtration rate < 15 mL/min/1.73m2
- •Recent or planned major surgery (such as gastric bypass operation)
- •Major psychiatric disorders, mental incapacity, unwillingness or language barrier precluding adequate understanding of the trial procedure or cooperation with the trial site personnel
- •Life-threatening disease including malignant neoplasms and medical history of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer)
结局指标
主要结局
HbA1c
时间窗: 26 weeks
Change from baseline HbA1c
次要结局
- Fasting plasma glucose(26 weeks)
- Hypoglycemia(26 weeks)
- Achieving treatment target(26 weeks)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
不适用
The Mobile Diabetes Mgmt. Study With Type 2 DiabetesType 2 DiabetesNCT02451631Healthconnect184
已完成
2 期
A Study of GSK256073 in Subjects With Type 2 Diabetes Mellitus Who Are Being Treated With MetforminDiabetes Mellitus, Type 2NCT01376323GlaxoSmithKline92
已完成
3 期
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)Chronic Obstructive Pulmonary Disease (COPD)NCT00383435Organon and Co1,055
已完成
3 期
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)Chronic Obstructive Pulmonary Disease (COPD)NCT00383721Organon and Co1,196
已完成
4 期
A Type 2 Diabetes Study of the Longer-Term Glycemic Effect of AVANDAMET vs. MetforminDiabetes Mellitus, Type 2NCT00386100GlaxoSmithKline688