Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 8
- 主要终点
- Proportion of participants achieving drug-free diabetes remission
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 IDegLira, 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 16-week course of treatment with IDegLira, metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with HbA1C<7.3% at the 16 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;
- •T2D diagnosed within 5 years
- •stable T2D drug regimen in the 8 weeks before randomization;
- •HbA1c 6.5-9.5% on no glucose lowering drugs, or 6.5%-8.0% on up to 2 glucose lowering drugs;
- •body mass index ≥ 23 kg/m2;
- •ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
- •willingness to wear a continuous glucose monitor on at least 3 occasions;
- •ability and willingness to self-inject IDegLira and insulin;
- •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 eGFR<45 mL/min/1.73 m2 by MDRD formula;
- •active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times the upper limit of normal at the time of enrolment;
- •history or clinical suspicion of pancreatitis or medullary thyroid cancer;
- •diagnosis or first degree relative with Multiple Endocrine Neoplasia Type 2 (MEN2);
- •history of diabetic retinopathy requiring photocoagulation, injection therapy or vitrectomy;
- •history of 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 insulin degludec, liraglutide or metformin.
研究组 & 干预措施
Intervention
Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: IDegLira (Drug)
Intervention
Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: insulin degludec (Drug)
Intervention
Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: Metformin (Drug)
Intervention
Drug: IDegLira - sc injection; Drug: metformin - oral administration; Drug: insulin degludec - sc injection; Behavioral: lifestyle therapy, diet and exercise
干预措施: Lifestyle Therapy (Behavioral)
结局指标
主要结局
Proportion of participants achieving drug-free diabetes remission
时间窗: 28 weeks after randomization
Drug-free diabetes remission is defined as HbA1C \< 6.5 % off glucose-lowering agents for at least 12 weeks.
次要结局
- Proportion of participants achieving drug-free diabetes remission(28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization)
- Proportion of participants achieving drug-free normoglycemia(28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization)
- Proportion of participants achieving drug-free diabetes regression(28 weeks, 40 weeks, 52 weeks and 68 weeks after randomization)