Remission Evaluation of Metabolic Interventions in Type 2 Diabetes (REMIT): A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Normoglycemia on Therapy
研究概览
简要总结
The purpose of this pilot trial is to determine whether an intensive treatment with insulin glargine, metformin, acarbose and lifestyle can normalize blood glucose levels in patients with recently diagnosed type 2 diabetes mellitus when compared to standard diabetes care.
详细描述
This is a pilot trial of 125 patients allocated to either usual care (1/3), 2 months or 4 months of intensive lifestyle and pharmacotherapy followed by cessation of all drug therapy.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women 30-80 years of age inclusive
- •type 2 diabetes mellitus diagnosed by a physician within 3 years prior to patient enrollment
- •anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks prior to screening and randomization
- •HbA1C ≤ 8.5% on no oral hypoglycemic agents or HbA1C ≤ 7.5% on 1 agent or on half-maximal doses of 2 agents
- •body mass index ≥ 23 kg/m2
- •a negative pregnancy test and an agreement to use a reliable method of birth control for the duration of the trial in all females with childbearing potential
- •ability and willingness to perform self-monitoring of capillary blood glucose (SMBG)
- •ability and willingness to self-inject insulin
- •provision of informed consent.
排除标准
- •current use of insulin therapy
- •history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance
- •renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l
- •history of lactic acidosis or diabetic ketoacidosis
- •active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper limit of normal at the time of enrollment
- •history of inflammatory bowel disease, colonic ulcers, recent or significant bowel surgery, or predisposition to bowel obstruction
- •cardiovascular disease including any of:
- •systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- •peripheral vascular disease
- •left bundle branch block or third degree AV block
- •tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate
- •stenotic valvular heart disease
- •cardiomyopathy
- •history of heart failure
- •history of aortic dissection
- •documented history of angina or coronary artery disease
- •history of stroke or transient ischemic attack
- •pulmonary disease with dependence on oxygen
- •history of any disease requiring intermittent or continuous systemic glucocorticoid treatment
- •history of any major illness with a life expectancy of <3 years
- •history of injury or any other condition that significantly limits participant's ability to achieve moderate levels of physical activity
- •any history of excessive alcohol intake, acute or chronic
- •known hypersensitivity to metformin, acarbose, or insulin glargine.
研究组 & 干预措施
Group 1 (short)
干预措施: insulin glargine (Drug)
Group 1 (short)
干预措施: metformin (Drug)
Group 1 (short)
干预措施: acarbose (Drug)
Group 1 (short)
干预措施: lifestyle therapy (Behavioral)
Group 2 (long)
干预措施: insulin glargine (Drug)
Group 2 (long)
干预措施: metformin (Drug)
Group 2 (long)
干预措施: acarbose (Drug)
Group 2 (long)
干预措施: lifestyle therapy (Behavioral)
Standard care
干预措施: Standard glycemic care (Other)
结局指标
主要结局
Normoglycemia on Therapy
时间窗: (1) 8 weeks and (2) 16 weeks
1. Percentage of participants achieving normoglycemia on therapy in the experimental group 1 compared to the control group. 2. Percentage of participants achieving normoglycemia on therapy in the experimental group 2 compared to the control group. Normoglycemia on therapy is defined as a mean fasting capillary blood glucose \</=5.4 mmol/L and a mean 2-hour pc blood glucose \</=6.8 mmol/L on 2 seven-point glucose profiles.
次要结局
- 1) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 1 Compared to the Control Group. 2) Percentage of Participants With Normal Glucose Tolerance in the Experimental Group 2 Compared to the Control Group.((1) 20 weeks and (2) 28 weeks)
- Percentage of Participants With Normal Fasting Plasma Glucose(52 weeks)
- Number of Participants With Severe Hypoglycemic Episodes(52 weeks)
- Change in Fasting Plasma Glucose From Baseline(Baseline and 52 weeks)
- HbA1C(8, 20, 28 and 52 weeks)
- Change in Weight From Baseline(Baseline, 8, 20, 28 and 52 weeks)
- Number of Participants With Symptomatic Hypoglycemic Episodes(52 weeks)
研究者
Dr. Hertzel Gerstein
Director, Division of Endocrinology and Metabolism, McMaster University
Population Health Research Institute