Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IGlarLixi
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 8
- 主要终点
- The first occurrence of diabetes relapse
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 iGlarLixi, metformin, 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 160 patients with recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week course of treatment with iGlarLixi, metformin and lifestyle therapy, and (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 experience hyperglycemia 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 aged 30-80 years;
- •type 2 diabetes mellitus within 5 years of diagnosis;
- •stable diabetes drug regimen in the 10 weeks before randomization;
- •HbA1c 6.5-9.5% on no glucose lowering drugs, or </= 8.5% on 1 glucose-lowering drug, or </= 8.0% on 2 glucose lowering drugs;
- •body mass index >/= 23 kg/m2;
- •ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
- •ability and willingness to self-inject iglarlixi; and
- •provision of informed consent.
排除标准
- •current use of insulin therapy;
- •history of hypoglycemia unawareness, or severe hypoglycemia requiring assistance;
- •history of end-stage renal disease or renal dysfunction as evidenced by eGFR<45 mL/min/1.73 m2 by MDRD formula;
- •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 enrolment;
- •history or clinical suspicion of pancreatitis or medullary thyroid cancer, or a calcitonin level >/= 20 pg/ml;
- •cardiovascular disease (unless cleared for a moderate intensity exercise program by a specialist) including: i. acute coronary syndrome, hospitalization for unstable angina, myocardial infarction, or revascularization with coronary artery bypass grafting or percutaneous coronary intervention; ii. peripheral vascular disease, valvular heart disease, cardiomyopathy, aortic dissection, tachyarrhythmias, bradyarrhythmias, prior stroke or TIA; iii. prior hospitalization for heart failure; or iv. ECG findings concerning for ischemic heart disease (i.e. pathological Q-waves, ST-segment-T-wave abnormalities in contiguous leads, left anterior hemiblock, left bundle branch block, second or third degree atrioventricular block).
- •history of any disease requiring frequent intermittent or continuous systemic glucocorticoid treatment;
- •history of bariatric surgery, or planned bariatric surgery in the next 1.5 years;
- •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 intake, acute or chronic;
- •currently pregnant, or breastfeeding, or not using a reliable method of birth control for the duration of the trial in all females with childbearing potential;
- •inability to take glargine, lixisenatide or metformin
研究组 & 干预措施
Intervention
Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: iGlarLixi (Drug)
Intervention
Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: Insulin Glargine (Drug)
Intervention
Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: Metformin (Drug)
Intervention
Drug: iGlarLixi - sc injection; Drug: metformin - oral administration; Drug: insulin glargine - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: Lifestyle therapy (Behavioral)
结局指标
主要结局
The first occurrence of diabetes relapse
时间窗: 64 weeks of follow-up
次要结局
- Number of participants achieving drug-free diabetes remission(24 weeks after randomization)
- Number of participants achieving drug-free normoglycemia defined as HbA1C < 6.0% off diabetes drugs for at least 12 weeks(24 weeks after randomization)
- Percentage of weight loss from baseline(12 weeks)
- Change in waist circumference from baseline(12 weeks)
- Glycated hemoglobin (HbA1C)(12 weeks)