An Open-label, Randomized, Parallel Design Trial to Compare the Efficacy of a Sitagliptin-based Metabolic Intervention Versus Standard Diabetes Therapy in Inducing Remission of Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Number of Participants With Severe Hypoglycemic Episodes
研究概览
简要总结
The purpose of the study is to determine whether in patients with early type 2 diabetes,a short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission.
详细描述
This is a multicentre, open-label, randomized controlled trial in 100 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with sitagliptin, metformin, insulin glargine and lifestyle therapy, or (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In all participants with HbA1C < 7.3% at the 12 week visit, glucose-lowering medications will be discontinued and participants will be encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who meet criteria for hyperglycemic relapse after stopping drugs will receive standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines
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 5 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 ≤ 9.5% on no oral hypoglycemic agents or HbA1C ≤ 8.0% on 1 oral 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;
- •history of hypoglycemia unawareness; history of severe hypoglycemia requiring assistance within the last 5 years;
- •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 pancreatitis;
- •cardiovascular disease including any of: a) systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg; b) peripheral vascular disease; c) left bundle branch block or second or third degree AV block; d) tachyarrhythmias or bradyarrhythmias with uncontrolled ventricular rate; e) stenotic valvular heart disease; f) cardiomyopathy; g) history of heart failure; h) history of aortic dissection; i) documented history of angina or coronary artery disease; j) history of stroke or transient ischemic attack;
- •history of any disease requiring 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;
- •excessive alcohol consumption (>14 alcoholic drinks per week in men and >7 alcoholic drinks per week in women);
- •known hypersensitivity to insulin glargine, metformin, or any DPP-4 inhibitor.
研究组 & 干预措施
Intervention
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
干预措施: insulin glargine (Drug)
Intervention
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
干预措施: sitagliptin/metformin (Drug)
Intervention
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
干预措施: lifestyle therapy (Behavioral)
结局指标
主要结局
Number of Participants With Severe Hypoglycemic Episodes
时间窗: 64 weeks of follow-up
Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group
时间窗: 64 weeks of follow-up
Hyperglycemia relapse for primary outcome was defined as any one of: 1. Capillary glucose \>10 mmol/L on \>/=50% of readings over 1 week; 2. HbA1C \>/=6.5%; 3. use of diabetes drugs; 4. fasting plasma glucose \>/= 7.0 mmol/L; 5. 2-hour postprandial plasma glucose \>/=11.1 mmol/L on an oral glucose tolerance test.
次要结局
- Number of Participants Achieving Drug-free Diabetes Remission(24 weeks after randomization)
- Change in Waist Circumference(Baseline and 12 weeks after randomization)
- Percent Change in Weight(Baseline and 12 weeks after randomization)
- Number of Participants With Drug-free Normal Glucose Tolerance(24 weeks after randomization)