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临床试验/NCT03862716
NCT03862716已完成3 期

Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira (REMIT IDegLira): A Randomized Controlled Trial

Population Health Research Institute8 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2019年4月23日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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