CSP #465 - Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,791
- 试验地点
- 21
- 主要终点
- Primary Major Macrovascular Events
研究概览
简要总结
This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
详细描述
Primary Hypothesis: Intensive glycemic control reduces major macrovascular morbidity and mortality compared to standard glycemic control in type 2 diabetics who have failed simple therapy.
Secondary Hypotheses: Intensive glycemic control, compared to standard glycemic control, reduces other macrovascular morbidity and total mortality.
Intervention: The intervention is tight glycemic control, aiming at normalization of HbA1c. This will be achieved through stepped care therapy, using all categories of tools available to most diabetologists. These categories include: patient education of diabetes control (e.g. diet, exercise, etc.), oral diabetes medications, and insulin. All drugs to be used are approved. Specific agents will be used within the different classes to promote consistency across sites.
The comparison is standard control, aiming at HbA1c of 8 - 9%. The same agents will be used, but at reduced doses.
The general approach to the stepped care treatment protocol is to treat both groups with the same agents, but at different intensities (doses) (taking into account intolerance/contraindications). The sequence of steps is shown below.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.
排除标准
- •Angina pectoris, Canadian Class I-II,
- •congestive heart failure, Class III-IV,
- •stroke, incapacitating or in last 6 months,
- •Myocardial infarction (MI) or invasive cardiovascular procedure within the past six months,
- •ongoing diabetic gangrene,
- •BMI > 40,
- •hemoglobinopathy that interferes with A1c monitoring,
- •serum creatinine > 1.6 mg/dL,
- •fasting C-peptide < 0.21 pmol/ml,
- •Alanine Amino Transaminase (ALT) > 3 times normal or serum bilirubin > 1.9 mg/dL,
- •malignancy or noncardiac life-threatening diseases making life expectancy < 5 years,
- •autonomic neuropathy,
- •symptomatic pancreatic insufficiency (endocrine or exocrine),
- •recurrent seizures within the past year,
- •hypopituitarism,
- •pregnancy, lactation, or planning a pregnancy,
- •active psychosis or substance abuse,
- •lack of access to a person who can assist or be called in an emergency,
- •underlying conditions that in the site PI's judgment may prevent adherence to protocol,
- •current participation in another clinical trial
研究组 & 干预措施
Standard glycemic control
Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
干预措施: Insulin (Drug)
Standard glycemic control
Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
干预措施: Glimepiride (Drug)
Standard glycemic control
Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
干预措施: Rosiglitazone (Drug)
Standard glycemic control
Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
干预措施: Metformin (Drug)
Intensive glycemic control
Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
干预措施: Insulin (Drug)
Intensive glycemic control
Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
干预措施: Glimepiride (Drug)
Intensive glycemic control
Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
干预措施: Rosiglitazone (Drug)
Intensive glycemic control
Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
干预措施: Metformin (Drug)
结局指标
主要结局
Primary Major Macrovascular Events
时间窗: Post baseline time to the first major macrovascular event up to 82 months
Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.
次要结局
- Secondary Endpoint(Post baseline time to first event up to 82 months)